Careers at I3 Infotek

• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
• Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary
• Revise, review and approve verification and validation activities as required.
• Review and approve any required drawing updates, including design impact assessments.
• Review and approve any labeling updates, including design impact assessments.
• Deliverables to be quarterly based on assigned files.
• Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support f
• Provide leadership in the understanding of medical device regulations to other discipline
• Ability to work in a team setting within Design Quality and cross-functionally is required.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Report task progress and status on a weekly basis.

• Update the Redlines for Design Control documents, provide feedback and recommendation for identified issues.
• Review and assess the complete DHF for various product line and device history file documents for planning.
• Review primary missing documents for Design Input and Design Output, Design Product requirements, Design Customer requirements and Applicable standards/ Essential requirements.
• Verify Design History File (DHF) deliverables, review the deliverables and perform GAP analysis.
• Provide input for changes in the Design Customer requirements.
• Update the Design Customer requirements procedures to ensure compliance with 21 CFR820, ISO 10993, International and FDA regulatory and safety standards.
• Evaluate and implement changes for the Design Input/Design Output documents.
• Create Work Instructions, update SOPs and ensure compliance with the governing rules and regulations
• Enhanced ability to implement projects and compliance programs, understand policies and procedures and governing compliance requirements for medical devices.

• Updated the Design Control procedures to ensure compliance with 21 CFR 820.

• Participated in product development team meetings, representing Quality.
• Performed risk evaluation of findings to define criticality and prioritize remediation activities.
• Tracked and maintained compliance records and documents
• Reviewed documents, including Risk Analysis, FMEA, Technical Reports, product labeling and marketing literature.
• Performed assessments on previously validated Design Verification and Validation documents.
• Set up design and development process as per 21 CFR 820.30, ISO13485 and ISO 10993 requirements
• Work with the SMEs and internal and external Reviewers to identify gaps and mitigate the risks
• Performed risk evaluation of findings to define criticality and prioritize remediation activities.

• Editing and preparing new/revised Design History Files and Design Control Documents that are submitted for the design control process.
• Write protocols, execute validations, understand regulations, and make decisions
• Go into validation packages and strengthen them, rational, re-execution, process to process, site to site
• Redlines and Incorporates Assembly Procedure word files as required
• Creates and Updates device configuration control documents as necessary
• Interacts with related departments as necessary to ensure that redlined changes are implemented accurately including ensuring required training
• Establishes change orders and prepares for change authorization and documentation
• Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, manufacturing
• Provides electronic storage for records retention to create images of documents and records. Indexes and organizes records based on standardized cross-filing system which can be retrieved in a timely manner
• Monitors record retention of all documents and coordinates records retrieval from electronic and physical storages as requested

Bachelors Degree in Biomedical Engineering, Pharmacists, Chemical engineering, or related field.

• Drive functional excellence initiatives, deliver high quality functional deliverables, and ensure technical excellence for product or technical development
• Study product characteristics or customer requirements to determine validation objectives and standards
•  Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems
• Provide significant guidance and approval regarding technical strategies and approaches on product and technology development projects
• Develop validation master plans, process flow diagrams, test cases, or standard operating procedures
•  Work cross-functionally in identifying and resolving technical issues, take a pro-active role in building bridges across the organization to mitigate issues.
• Drive and evaluate project and department progress, technical development plans, and results.
• Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols
• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• Communicate with regulatory agencies regarding compliance documentation or validation results.
• Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• Work with other members to ensure cross-training and provide back-up support.

Bachelor’s degree required in Biomedical engineering, Pharmacists, Chemical engineering or closely related field

• Involved in developing and supporting the integration between Siebel, Salesforce and Microsoft Dynamics 365 by using webMethods Enterprise Gateway.
• Involved in creating the technical design documents.
• Involved in establishing the connectivity with Sales force and Microsoft Dynamics 365.
• Involved in establishing the connectivity with Siebel and Microsoft Dynamics 365.
• Developed flow services and Siebel adapters.
• Developed and supported complex interfaces between business systems internal to webMethods  with external partners
• Good knowledge on handling of large flat files.
• Migrated most of the interfaces from Salesforce to Microsoft Dynamics 365.
• Efficient in writing reusable, testable, and efficient code.
• Supporting the integration and user acceptance testing and trouble shoot bugs and provide fixes.
• Supporting the integrations and involved in operations of the webMethods application.
• Supporting the webMethods environment and resolving the issues.

Gathering Business requirements

• Work with the business users, vendors etc. to understand the business needs and translate them into business requirements.
• Conduct JAD sessions, interviews, brain storming sessions to elicit and fine tune the requirements.
• Create and maintain the business requirements documents.

Data Analysis

• Perform data analysis on the existing requirements and reports to understand the data.
• Identify, analyze and interpret trends/patterns on complex data sets.
• Present the results of the analysis to stakeholders and understand the impact of data.

Data Acquisition

• Acquire data from primary and secondary sources and organize the information logically.
• Work with the database administrators and developers to extract, transform and load data and
  ensure appropriate movement of data.
• Provide an analysis of the existing processes and provide recommendations for streamlining the process.

Business Intelligence/ Reporting

• Analyze the existing cognos and tableau dashboards and reports.
• Helps develop and support customer facing reports and analytics.
• Assist the developers in identifying revising the reports and requirements.

• Understanding the needs of multiple stakeholders
• Facilitating the negotiation of requirements amongst multiple stakeholders.
• Identifying the current- and future-state business processes.
• Helping the business stakeholders envision the future and how their work will need to change to support the future.
• Partner with stakeholders to understand the problems they’re trying to solve, and structure analysis to address their business needs.
• Due to strong technical and business acumen I am able to communicate and understand the concerns and new requirements by interacting with various stakeholders including legal, compliance, business and third parties.
• Strong understanding of Travel industry and back office transactions on how any reservation done at the frontend using American Express flows through all the downstream systems.
• Handling all the financial aspects of the transactions for the 22 global markets which include tax, service fees, travel vouchers, market redemption, etc.
• Coming up with creative ideas on how to improve the Central Command Product from performance, customer perspective and add new features to increase revenue.
• Performing PI planning and Sprint planning to effectively deliver the projects and also determine budget and capacity required.
• Performing quarterly health check of the system in order to deliver smooth experience.
• Creating, analyzing, and validating detailed functional specifications.
• Facilitating design sessions with the implementation team to define the solution.
• Delivering elements of systems design, including data migration rules, business rules, wireframes, or other detailed deliverables.
• Be able to independently gather requirements around Central Command Product and produce clear, actionable business user stories for technical teams.
• Documenting, grooming and prioritizing the user stories during sprint ceremonies with technical team and able to demonstrate product changes/deliverables with stakeholders.
• Following an agile/scrum methodology in delivering the project and extensive use of Rally.
• Understanding and resolving conflicts between various stakeholders by understanding the system architect and different stakeholders involved.
• Planning and monitoring various user stories and multiple projects using Rally for the back office product.
• Testing and validating the requirements configured before delivering it to the stakeholders and making sure it meets the acceptance criteria.
• Be the link between stakeholders and technical team to timely deliver projects.

Bachelor’s Degree required in quantitative and business related field.

• Leading and prioritize the Application Support team’s work load.
• Manage and Own the Problem Management Process.
• Develop, co-ordinate and promote the effective functioning of problem management activities across all of support teams
• To examine potential areas for Service Improvement and raise proposals with the Service Manager • Provide technical leadership.
• Maintain application monitoring, performance tuning and testing
• Documenting the reports obtained from the team members and presenting them to the senior leadership.
• Identify training needs or requirements for yourself individually and for the team • Manning P1/P2 Bridge Calls.
• Daily Interaction with business partners and other stake holders for analysis of the technicalities and the planning of the migration activities.
• Develop new programs, procedures, jobs, new online screens for the LifeComm Rolling project utilizing COBOL II, VSAM, DB2, IMS, CICS, JCL, File-Aid, Xpediter, OS/MVS, TSO/ISPF, IBM Mainframe, and Microsoft Office.
• Changes in the existing batch programs to create the new reports, provide Unit Testing, System integration testing, updated program and system documentation, and wrote technical specifications
• Identifying and controlling the operational Risk factors, ensuring their sensible controls for current situations and future changes in the project.
• Identification of common integration points across multiple mainframe applications and determining the best approach for checkout of these points.
• Automation of checkout of common integration points across multiple mainframe applications.The automation is for checkout of IMS databases, DB2 tables, CICS online regions, FTP servers, VSAM batch and online files, Endeavor, IMS batch functionality and multiple IBM and customer utilities. All the mainframe tools were identified and checked out as generic checkout.
• Proficiency in business modeling and requirements definition disciplines through Unified Modeling Language (UML), use cases.
• Identification of functionalities which needs to be covered manually, get reviewed by multiple stakeholders and base lining the result.
• Involve in Requirement, Impact Analysis, Estimation, Designing, Coding, Testing and Quality processes.
• Generate various reports requested by business using requested criteria.
• Analyzing the business and functional requirements and developed Test Plans, high level Test Scenarios, Test Scripts, Estimates to facilitate the process of testing.  
• Production trouble-shooting of CICS screens to resolve service requests.
• Responsible for estimation Effort for test execution and preparing reports and Metrics and data to upper level management folks.
• Implementation of Business cases and technical initiatives.
• Suggest and implement Performance improvements.
• Responsible for reporting the Accomplishments and Metrics on a weekly basis.
• Analyze Existing Applications, Functional Specification Documents and Use Cases.
• Code development and Analysis as per the requirements.
• Designing SQL queries while performing database testing.
• Involve in Version control for project documents.
• Preparation and planning for migration weekend for managing mainframe and midrange jobs.
• Planning of jobs which needs to be released post migration once migration is complete.
• Satisfying business needs while maintaining compliance, following IBM and AGCS standards and IBM quality process.
• Adept in all facets of Software Development Life Cycle (SDLC)
• Participate in project review meetings with customer and onshore/offshore PMO team.
• Coordination with client business and IT teams and also with onshore and offshore teams to ensure smooth resolution of all open issues during the planning and execution of the project.

Bachelor's Degree required in Engineering or related fields.

• UML for designing of application diagram like use case diagrams, block diagram, high level diagram and low level diagrams.
• Proof of concept for design documents.
• Writing unit test cases.
• Image processing from ultrasound.
•  Working on shared memory.
•  CUDA programming.
• Developing advanced level programming in C++ including shared pointers, multi threading, thread synchronization, multi-processing, concurrency, and TCP/IP Socket Programming.
• Developing  data structures and algorithms.
• Developing Android applications, services.
• Developing Language translations in runtime and custom translation for specific text based on client requirement.
• Working in shared libraries.
• Working in database programing using SQL.
• Executing unit test cases.
• Using PerForce for source code control, followed Agile and Scrum Methodologies.
• Participating in code reviews.
• Ability to investigate, troubleshoot and identify solutions to issues during development.
• Utilizes necessary tools to measure software performance.
• Writing python script files.
• Executing Behavior Driven Development & Testing(BDD) with Squish for implemented features.
• Establish jenkins build setup for continuous integration and build manage for daily builds for QA, production release.
• Debugging and bug fixing the issues that are identified.

• Install and maintain all DBMS and related software.
• Establish and maintain all DBMS operating environments (UAT, Production and COB) on hosts/servers in TI Data      Centers.
• Establish and document DBMS operating standards and procedures. 
• Establish and maintain physical backup and recovery processes for all DBMS environments. 
• Recover DBMS subsystem and support database recovery at the contingency site. 
• Research and resolve DBMS system problems and assist in the resolution of application problems. 
• Establish DBMS system security standards and support Security Administration in maintaining access controls.
• Monitor performance and tune all DBMS subsystems. Support application performance review and tuning efforts. 
• Provide 24 / 7 Database Hotline support for production systems.
• To check and ensure appropriate OS patch levels are applied on the hosts 
• To analyze system software requirements and provide the SA team with file system size information.
• To upgrade DBMS software and apply patches, as per the corporate standards 
• To maintain and standardize documents for setting up new and existing servers
• To apply configuration changes from UAT to PROD/COB servers 
• To fine tune configurations based on system load, response needs and inputs from app DBAs 
• To process STRs/SIRs related to infrastructures changes and problems. 
• To provide weekend support, whenever pre-scheduled off business hour work, is being performed
• To provide database recovery support for various database disasters 
• To maintain active COB (Continuity of Business) server on a different host
• To manage database space  
• To resolve errors and system warnings/messages 
• To monitor production server resources performance 
• To work with vendors as necessary on problems 
• Responsible for configuring and scheduling physical database backups using certified scheduling agent with proper        escalation details

• Gathering the requirement from the Client during the meeting and design the work flow, timeline .
• Analyzing the technical aspects for the task and start the implementation using PL/SQL database queries.
• Designing the reports using Congos for the data flow about the end users data and the services provided.
• Created List Reports, Crosstab Reports, Chart Reports, Drill-Down and Drill-Through Reports.
• Gathered and analyzed business requirements from business users during every sessions of meeting for modification and improvement in the task.
• Implement the design reports using prompts, filters, query calculations, cascading prompts and conditional formatting using Report Studio.
• Applied Data level security, Object level security prior to Publishing packages to Cognos Connection.
• Design and implement complex reports using drill-through and Master Detail functionalities in Report Studio.
• Created the Cognos Report Studio reports for EIS model.
• Unit testing, integration testing and system testing of the reports in development, performance and production environments.
• Trained users on Query Studio for Ad-Hoc reporting.
• Understanding the business requirement and pointing the drawbacks and modifications required from the end user.
• Application architect will be co-ordinating the changes required and gathering the requirements.
• Software requirements should be met by the development team in order to implement the task provided.

Bachelor’s Degree required in Science or a closely related field.

• compile customer requirements for communication tools; translate these requirements into system schematics and requirements specifications; drive these requirements into the design organization
• Act as the primary interface to both internal and external customers.
• Collect requirements, evaluate compliance, and note areas of nonconformance and/or opportunities for requirement modification based on experience
• Develop System Specifications according to agreed-upon customer requirements
• Liaise with the Engineering, Service and Production teams to technically analyses, develop and allocate system requirements
• Support customer system integration efforts through appropriate means such as conference calls, data log analysis, and travel to customer sites.
• Coordinate activities of electrical hardware and software teams to resolve issues
• Develop and maintain realistic project milestones and deliverables using appropriate tools. Track and report project status and Proactively manage changes in project scope
• Ensure team follows established development processes, contribute to process improvement activities, Develop best practices and tools for project execution and management
• Demonstrated technical writing skills in English
• Requirement management (includes VOC collection, interpretation) experience in embedded SW
• Understanding of SW V model
• Awareness of Cyber security, Autosar, Automotive
• Functional Safety (FS) ISO 26262, CAN, Ethernet

Bachelor’s Degree required in Science or related field.

• Responsible for the fundamental organization of a system embodied in its components, their relationships to each other, and to the environment and the principles guiding its design and evolution.
• Functions to create the conceptual, high-level, and detailed design of the software solution.
• Develops the logical data model (LDM) and assists the DBA in developing the physical data model (PDM).
• Facilitates JAD sessions to determine data rules and holds LDM and PDM reviews with Data SMEs. 
• Applies Capital One Data Naming Standards, checks models in and out of Model Repository, and documents data model translation decisions.
• Use of data profiling tools and techniques and development of review and QA data requirements.

Bachelor’s Degree required in Technology, Science, Engineering or related field.

• Drive SOP/WI updates or creation of new processes based upon upcoming standards or process improvements.
• Collaborate with project/program teams to ensure work products comply with procedures, acceptable qualitative        and quantitative criteria, and global standards, regulations, and guidance.
• Generate documentation at the project level including risk assessment per ISO14971, DFMEA, PFMEA
• Perform and lead CAPA projects and activities.
• Work and review incoming inspection report
• Support and provide guidance on Validations

Bachelor’s Degree required in Pharmaceutical Science.

• Design, Develop and Implement validation of different moderately complex to complex manufacturing and laboratory equipment from installation to retirement by following GxP practices, company procedures and regulatory requirements
• Provide technical and operational support (procedural) for the use of equipment, develop and execute IQ/OQ protocols and performance specific process related qualification documents to validate the equipment to ensure they meet regulatory requirements and process specifications per manufacturing products
• Perform Design of Experiment and research for the parametric change of the parameters that play key role in high volume manufacturing in a production environment. Write and execute validation protocols by collaborating with quality control and product engineering team to meet the quality standards as per FDA regulations to develop suitable test methods and associated instruments
• Work with the SMEs, Quality Engineers and Product owners to gather User Requirements for the equipment, determine risk and develop and optimize product manufacturing related processes and associated process flow diagrams and Standard Operating procedures for shop-floor execution.
• Perform Risk management using ISO 14971 in the risk management program, including FMEA, risk reduction strategies by coordinating with quality team for better quality of the products and improve the validation and business processes.
• Execute qualification protocols including IQ/OQ/PQ to verify that the equipment have been installed, configured, and released for appropriate use. Validate the operators using the equipment have required training materials and complete training before use of equipment for safety and regulatory purpose.
• Work with Equipment manufacturers, vendors and technicians to review equipment turn-over-packages and coordinate planned and controlled execution of Site Acceptance tests and Engineering Change Controls. Gather, develop and prepare validation package for the cGMP equipment.
• Review Operator execution results, testing data results, temperature mapping reports to analyze and create data trends to identify potential risks, improvement opportunities and internal planning. Identify any existing deviations, perform risk and root-cause analysis and implement Corrective Action and Preventive Action to reduce the deviation from the actual process.
• Responsible for product life management (PLM) Agile environment by maintaining bill of materials (BOMs), guiding and mentoring less experienced engineers in initiating engineering change requests (ECR) and completing engineering change orders (ECO)

Work with the Management and cross-functional teams to determine the scope, schedule and drive successful closure of validation effort in time with business to ensure compliance with company procedures and FDA guidelines.

Bachelor’s Degree required in Science or related field.

• Lead successful implementations on Hortonworks 3.0, AWS, Oracle BDA and Azure based platforms for ETL, Data Science and Machine learning
• Deep technical, hands-on knowledge of the Hadoop ecosystem including Hive, HBase, Spark, Kafka, Solr, Falcon, Phoenix, Kylin and Atlas for Cloudera, Hortonworks, Azure and AWS based distributions
• Design and implementation of IP strategy for CVS Big Data platform
• Solution design / delivery for Cloud IaaS, PaaS and SaaS based models
• Setting up & managing CoEs for Hadoop, Teradata, Splunk and BI tools (Tableau, Cognos,      SAS)
• Setting up & managing virtual technology innovation labs at global level
• Quick proof-of-concepts for niche technologies like Big Data and BI
• Monitoring/troubleshooting hundreds of Linux servers divided across the
• globe and as a Senior System administrator I’m Responsible for effective provisioning, installation/configuration, operation, and maintenance of systems hardware and software and related infrastructure. We have multiple Hadoop clusters and as Hadoop administrator my responsibility is to keep them stable by configuring effective monitoring, timely upgrade, fix hardware issues, software issues, planned maintenance, fine tuning etc.

Bachelor’s Degree required in Computer Applications or related field.

•  Define and write clear and succinct technical documentation related to systems and application Engineering.
• Create procedures and scripts for automating and streamlining repeatable processes during server integrations and large scale application rollout.
• Develop server maintenance plans and introduce technologies that add value to the data center resources and services
• Define and execute process of server patching, OS upgrades, and engineering change requests.
• Configure and maintain Oracle and DB2 Databases
• Monitor and maintain health, performance, and security of the infrastructure
• Resolve UNIX and Linux based server support problems in a global enterprise environment through resourceful troubleshooting, root cause analysis, and best practice solutions that prevent recurrence.
• Recognize opportunities to improve customer satisfaction by taking ownership of engineering challenges and support issues, establishing realistic expectations, then executing solutions with favorable outcomes.
• Provide 24 X 7 on-call UNIX, Windows and Linux support on a rotating schedule basis.
• Mentor and assist junior level system administrators who work inside the Remote Network Operations Center (RNOC) and share knowledge with engineering colleagues who are interested in learning about areas of advanced expertise
• Work with Development teams and other IT department personnel to coordinate system software changes and support application changes
• Manage server life-cycles and inventory by analyzing older legacy systems, and assessing options for upgrading, consolidating, or disposal. Utilize available resources for capacity planning and performance analysis, and identifying resources needed to put plans into action. 

Bachelor’s Degree required in Computer Science.

• Create and manage Power center Repositories and Integration services.
• Create and Configuration Power Exchange CDC Environments listener and Logger.
• Installation Informatica Power Exchange CDC Navigator 9.6.1 on windows 7/8.Creating Registration groups in Informatica Power Exchange Navigator 9.6.1.
• Registration of CDC tables in Power Exchange Navigator for different source systems and Importing CDC tables in Power Center Designer.
• Create application connections for Power Exchange CDC real time and continues mode. Creating Registration Groups & Maps and Importing to Informatica 9.6.1 CDC Repositories.
• Monitor Memory / temp space usage and allocation and code deployment management.
• Design and develop Informatica mappings, Stored Procedure, UNIX scripts and Autosys jobs.
• Manage infrastructure through incident and problem resolution and project work requests, engineer solutions through change management.
• Developing Automation process like repository backup, restart/reboot the server and connection / user privilege management in Agile SDLC methodology.
• Serve as a subject matter expert on Informatica, Netezza and Autosys and provide direction and guidance to other project members.
• Ensures compliance with regulatory requirements for data transmission, storage, and data access including documentation, testing and remediation.
• Perform data munging and statistical analyses to better understand datasets before modeling.

Bachelor’s Degree required in Science, Information Technology or related field.

• Creating documentation of the processes included in the Quality Management System.
• Creating documented procedures on the relationship and sequence of the QMS processes.
• Creating Quality Manual outline the structure for the documentation used in the QMS
• Developing a preliminary essential requirements checklist if the new indication will be commercialized in the EU or other geographies that require in Phase I.
• Finalizing the Essential Requirements Checklist and update and release the Clinical Evaluation Report, as required for certain geographies.
• Updating the Clinical Evaluation Plan with a post-market surveillance and post-market clinical follow-up plan that appropriate monitors safety and performance post-launch.
• Developing the device safety characteristics considering its intended use
• Identifying hazards and potential harms, estimating the probability that harm might occur
• Assessing the severity of the consequent possible harm caused by a hazard and evaluate the associated risks
• Implementing necessary risk controls to decrease the risks As Far As Possible
• Evaluating the overall residual risk acceptability, and Monitoring the effectiveness of these risk controls using production and post-production information
• Assessing the risks associated with the new product or indication, including usage and security risks at the system level so that mitigations may be considered in the system design.
• Performing risk assessments of the automated process in order to define the scope of software validation for its intended use.
• Updating the process risk documentation (e.g. P-FMEA)to ensure company compliance to production and process controls requirements found in 21 CFR 820.70
• Participating in the investigation of any discrepancies noted during the course of the validation project
• Creating and ensuring protocols are appropriate and followed
• Gathering and ensuring requirements are met
• Creating and ensuring that manufacturing process software is properly specified in one or more documents
• Ensuring that custom code and customized configuration files are placed under configuration management
• Ensuring that any necessary peer reviews are conducted and documented in the EDMS by the validation team
• Participating in the investigation of any discrepancies noted during the course of the validation project
• Providing guidance with respect to validation protocol and report development and data collection.
• Creating test methods for some existing work instructions.
• Creating TMV protocols and reports by using Experienced in Statistical Data analysis in Minitab (Gage R&R, Anova studies) and Distribution analyzer.
• Creating design verification protocols/reports and test method to ensure each claim has supporting evidence in the DHF.
• Developing internal and supplier quality system procedures and processes to align them with company’s Standard Operating Procedures (SOPs). 

Bachelor’s Degree required in Science or related field.

• Working in Agile Environment and leading Scrum and its teams based on goals.
• Lead the project with Full stack technical skills and acts as an interface between the team and the project stakeholders.
• Team meeting where the progress of the project and any kind of show stoppers will be discussed. This will help the team to monitor closely if there are any dependencies from other teams or any road blocks that needs to be taken care of for the smooth progress of the project.
• As an Full Stack Technical Lead, the beneficiary give update regarding the Design and approval status of each interface in the current sprint to the Scrum master/Project manager
• Participate in Sprint planning and backlog grooming.
• Retrospection after each sprint to improve the Integrity of application
• Create/Write User stories in JIRA based on changes in acceptance criteria after the handshake with other components of the architecture
• Engage daily, weekly and Monthly status review meeting with key customer stakeholders - Managers, Directors and senior directors.

Bachelor’s Degree required in Science or related field.

• Improve the manufacturing process specifications for the production of new generation heart valves.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.    
• Implement periodic reviews and updates to the company procedures (GSOP) to align with the current standards.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis.
• Author and execute TMV's on the newly created process production specifications.
• Develop Inspection Method and Test Method Validation (TMV) Protocols and Reports.
• Write and oversee execution of Test Method Validation and perform attribute and variable test method validations (TMV).
• Assure compliance of test methods with SOPs and, where necessary, revise/originate SOPs for methods unique to product.
• Perform Test Method Validation (TMV) for equipment/processes utilizing statistics & gage R&R for analysis.
• Perform GAP Analysis and develop corresponding Remediation plan.
• Work hand in hand with R&D labs/ manufacturing engineers to answer questions related to application and use of quality tools viz. SPC, capability analysis.

Bachelor’s Degree required in Pharmaceutical Science.

• Quality Engineering working knowledge and Quality Management Experience
• working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements
• Risk Management Process
• Support non-conformance activities for their resolution
• Support CAPA activities for their closure
• Work and review incoming inspection report
• Support validation, protocol and Technical reports
• Quality reviews for documentation
• Interact with stakeholders for review and alignment
• Project Management support as needed
• support and provide guidance on Validations
• Create receiving inspection forms
• MSA, inspection equipment validation experience.
• SOP, WI create and revise, Change management activities to push the changes through

Bachelor's Degree required in Mechanical Engineering.

• Modify eSHARE database code in SQL Server database to incorporate changes requested by Program.
• Working with UI scripts Involving C# coding, .net framework
• Update and maintain database views, Functions, and jobs.
• Create and maintain Stored Procedures as needed
• Design, develop and update reports from database
• Optimize and troubleshoot views, stored procedures and other database objects.
• SSRS Reporting, Ad-hoc Reporting Using Tableau & Cognos
• Enhancements to the existing Reconciliations and Infrastructure 

           Enhancements

• Working on production support activities as part of escalations & emergencies.
• Testing the scripts to debug the performance at various levels of SDLC.
• Creating weekend, Month end cleanup and maintenance jobs. 
• Automating the lower lane server maintenance jobs and some of the production support tasks and activities.
• Designing Data models & Database objects to meet the complex business requirements into real time Reconciliations with accuracy.
• Worked on Microsoft Visual Studio to Program C# objects to Improve the UI Performance and eliminating the timeouts
• Use Coding Practices Adhere to Citi Standards.
• Quality Deliverables.
• Perform Auto Deployments.

Bachelor’s degree Required in Computer Science or Electrical Engineering or Computer Engineering or Information Technology.  

• Supplier Monitoring: Track Supplier performance metrics and trends to assist in supply base improvement.  Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Providing inputs in the design transfer or manufacturing transfers for New Product Introduction(NPI) to other sites or supplier locations.
• Responsible for the transfer of Class III medical devices to production and market release following the FDA Quality System Regulation, GLP, GMP Guidelines, Medical Device Directive, ISO 13485, and other international regulatory requirements.
• Setting up design and development process as per 21 CFR 820.30 & ISO13485 requirements.
• Supporting product launch and phase review processes - design reviews, product risk management, maintenance of DHF and review of documentation and Technical Files. 
• Be results-oriented and have the ability to complete deliverables against Project deadlines.
• Able to communicate effectively both orally and in written form to multiple levels of the company.
• Demonstrates characteristics of high potential for future development opportunities.
• Proficient with Microsoft Office Suite Applications.
• Supplier Selection & Evaluation: Perform Supplier Quality system assessments for risk and opportunity. Support Supplier selection process and technical reviews.
• Supplier Product Quality: Work with Suppliers through the supplier launch process and perform Production Part Approval / Sample submission reviews. Utilize AIAG methods as a model for PFMEA, Control Plan, MSA/Gauge R&R, and related requirements throughout the process.
• Ability to conduct Process Validation using IQ/OQ/PQ as per 21 CFR 820.75.
• Problem Solving: Assist the problem solving process to identify and resolve root cause(s) of nonconformities.  Issue Corrective and Preventive Actions (CAPA) to suppliers.
• Manage containment, follow- up and establish robust CAPAs while driving issues to permanent resolution. Utilize structured problem solving and Lean/Six-Sigma methodologies throughout the process.
• Knowledge of blueprint reading and geometric dimensioning & tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and the ability to use inspection, measurement and test equipment, such as hand gauges, optical comparators and CMMs.

Bachelor's degree required in Chemical Engineering or closely related field.

Date of Opening: 05/14/2019

Date of Closing: 06/14/2019

Seeking qualified Software Engineers w/Master’s degree or foreign equivalent in ENGG OR CS OR IT and 6 months of experience to Develop and Provide engineering support to the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. Design, architect, develop and implement business & service tier for client/server and web applications using Java, J2EE, Hibernate, C/C++, Perl, HTML, XML, PHP, Visual Basic, VB Script, Java Script, SQL Server, Oracle, Linux, Windows. Create and update design documents for the project defining the system behavior. Provide bug fixing and maintenance of implemented code within application area. Travel may be required to unanticipated offsite locations.

Aspiring Candidates can mail their resumes to:

HR Manager

i3 Infotek Inc.

379 Thornall Street, 9th Floor, Edison, NJ 08837

Job Loc: Edison, NJ 08837

• Dot Net Developer needs to do the following job duties:
• Involve in development of complex business using ASP.Net, C#, SQL, Entity Framework,  MVC, Java script, JQuery, BootStrap, CSS and other available technology, tools, and designs.
• Involve in performance tuning, SQL query enhancements, code enhancements to achieve performance targets.
• Design back-end database structures for the web applications and generating stored procedures, functions, scripts and triggers that are complex in nature.      
• Actively participate in all the phases of Project Life Cycle like gathering complex business requirements, development, unit testing, deployment, resolve any post-deployment issues and provide bug fixes.
• Optimize database systems for performance efficiency.
• Tune up design for maintainability, scalability and efficiency.  
• Perform production support activities such as monitor system processes, evaluate the outcome of system processes, work through system exceptions, and create processes to monitor and report on the overall system health.
• Participate in peer-reviews of solution design, related code, analyze and resolve technical and application problems
• Enhance existing systems by analyzing business objectives, preparing an action plan and identifying areas for modification and improvement.
• Work independently to understand the assigned work, deliver on agreed upon dates and raise issues/risks in a timely manner in case of risk to deliverable.

Degree Requirement: Baccalaureate program in Computer Applications or a closely related field

Development Quality Engineer needed to perform the following Job duties :

• •  Risk Management procedures development and remediation
    (The Risk Management process is essential for ensuring the quality of the product. Risk management process shall provide the method to evaluate the Product safety and effectiveness, with respect to the clinical condition and intended use, for the patients, users, and/or when applicable, other factors (such as environment or other persons) during the designated lifetime of the device.) As a Development Quality Engineer, developing risk management procedures involves:      
    • Develop Risk Management Procedure for identifying, assessing, controlling, and monitoring risks throughout all phases of the Total Product Life-Cycle. 
    • Create Risk Management Plans and Risk Management Reports. 
    • Define and document the policy for determining criteria for risk acceptability. 
    • Develop criteria for overall residual risk evaluation and corresponding risk benefit analysis. 
    • Review the suitability of the risk management process at planned intervals to ensure continuing effectiveness of the risk management process and document any decisions and actions taken. 
  • Prepares and/or reviews Standard Operating Procedures (SOPs) and Detailed Work Instructions (DWIs) (The International standards specifies a process for a manufacturer to identify hazards associated with medical devices, in vitro diagnostic /(IVD) medical devices, to estimate and evaluate the associated risks, to control these risks and to monitor the effectiveness of the controls) As a Development Quality Engineer, preparing SOPs and DWIs involves:
    • Apply EN ISO 14971 and EU MDR standards in preparing and remediating Product Development and Risk Management Standard Operating Procedures (SOPs) and Detailed Work Instructions (DWIs).
    • Identify gaps in SOPs according to standards in a timely manner.
  •  Performs component level (DFMECA and PFMECA) and System Level Risk Assessment(Risk Assessment is the overall process comprising risk analysis and risk evaluation. Risk assessment activities shall commence early in the design realization of the product per Product Development Procedure, and continue throughout the Total Product Life-Cycle) As a Development Quality Engineer, performing component and system level risk assessment involves:
    • Perform Mechanical Design Failure Mode Effect and Criticality Analysis (MDFMECA) and Process Failure Mode Effect and Criticality Analysis (PFMECA) for Cardiac Rhythm Management (CRM) products
    • Perform System level risk assessment based on the component interactions, product interactions, and environment interactions.
    • Identify failure modes, failure causes, corresponding severity of harm to patient and, probability of occurrence of harm at component, product, and overall system level.
    • Assess risk for patient for each failure of product during cross functional team discussion.
  • Perform Device Hazard Analysis and Software Hazard Analysis
    • Perform Hazard Analysis associated for Cardiac Rhythm Management (CRM) products which includes electrical, mechanical and software components according to ISO 14971 and FDA (Food and Drug Administration).
    • Responsible for breaking down the device to its lowest level of components and analyzing the individual component for all the possible Hazards in case of failure in functionality of the component.
  • Implements IMDRF codes and corresponding mapping of codes for risk files (The Risk Management Files are created on custom made software and database that need customization to standardize the Systems for all Risk Management activities. One such customization of the software required a mapping of all the complaint codes with the individual Hazard, Hazardous Situation and Harm to the patient to comply with international medical device regulatory harmonization and convergence)
    • Assign internationally approved codes for each failure mode and failure cause combination.
    • Create master list of all possible hazards, hazardous situations and harms mapping.
    • Ensure existing codes compliance with Food & Drug Administration (FDA), NCI and International Medical Device Regulatory Forum (IMDRF) standards.
    • Provide suggestions to the FDA, NCI and IMDRF standard coding systems to include new hazards associated with Cardiac Rhythm Management (CRM) products for component and system level failure modes.
  • Statistical Analysis for probability prediction(Probabilities (P1 (probability of a hazardous situation occurring), P2 (probability of the hazardous situation leading to harm), and P) may be estimated quantitatively or qualitatively. Quantitative estimates should use a direct probability value estimated from predicate product experience, clinical evidence, scientific literature, or other quantitative source. Qualitative estimates may be derived from expert opinion and shall use a scale of one (1) to five (5), representing quantitative ranges)
    • Derive predicate product experience probabilities for hazard analysis for each possible severity for a harm.
    • Perform probability prediction using Monte Carlo Simulation.
    • Prepare summary report for each product regarding overall chances of occurring a severity for a product and escalates the results to the higher management.
  • Post Market Surveillance review and associated risk management files update(Per ISO 14971, the Risk Management Files are constantly subjected to feedback from the market post-production and release of the product)
    • Review product performance during field usage and facilitates updates to the Risk Management File
    • Collect marketing data by various reporting tools (Complaints, NCMR and CAPA) and review analysis (Electrical, Mechanical, Software etc.) provided by the product technicians to provide coverage for existing and new hazards, hazardous situation and harms identified
  • Prepares and/or reviews plan for design transfer from the development phase to product launch(Abbott conducts design transfer to ensure that the device design is correctly translated and transferred into production specifications)
    • Prepare plan for transferring new designs as well as modifications or improvements to existing device designs to production specifications.
    • Ensure the product complies with regulatory requirements and industry standards.

Bachelor’s Degree required in  Mechanical Engineering or Industrial Engineering or Engineering Technology or Industrial & Technical Studies. 

• Develop project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
• Perform risk management to minimize project risks.
• Create and maintaining Project documentation in SharePoint.
• Develop a detailed project plan to track progress.
• Perform Impact analysis of the changes done to existing mappings in Informatica and provided feedback to management.
• Building and maintaining close relationships with internal customers and retail systems vendor to ensure efficient development processes are being followed and that business priorities are met, and that projects/development are on schedule

• Ensure the projects should deliver on-time, within scope and within budget.

• Manage  SAT, UAT and QA works, worked with governance and quality assurance & control teams

• Handled all phases of testing like Unit testing, component testing, integration testing, system testing, usability testing, service testing etc.

• Perform Root Cause Analysis Mechanisms. Identify the issue and define optimistic solution

• Critical Technical Production Issues Resolution:  Root Cause Analysis, Strong Debugging Techniques, Collaboration with various technical teams, Strong Understanding of business flows and integrated up stream & downstream applications.

• Perform debugging and Analytical skills to identify resolve the problem.

• Collaborate with support, business, and various technical teams

• Strong knowledge in Application and its connected applications

• Debug tools and strategies

• Log analysis techniques and problem investigation skills

• Capable of providing alternate solutions to avoid business process interruptions without compromising  compliance

• Guiding the delivery teams on computer system validation documentation and ELC (Enterprise Life Cycle) or SDLC (Solution Delivery Life Cycle) processes in compliance with 21 CFR Part11, GxP etc.

• Provide Operations support for the strategy and operations team.

• Managing story backlog and tracking items using TFS.RTC and JIRA 

• Created Epics, user stories and project tasks in Team foundation Server, RTC and JIRA.

• Measure project performance using appropriate systems, tools and technique.

• Reporting and escalate to management as needed.

• Manage the relationship with the client and all stakeholders.

• Perform risk management to minimize project risks.

• Establish and maintain relationships with third parties/vendor.

• Create and maintain comprehensive project documentation

• Perform test Driven Development with Good Code Coverage with unit tests.

• Project Governance: Code Reviews, Code Quality Analytics, Documentation, Unit Test Coverage Inspections, Software Factory Management, Code Check-ins, and Change Management & Deployments.

• Use Coding Practices Adhere USAA Quality Deliverables.

• Perform Auto Deployments.

• Compliant to Change Processes 

Bachelor’s Degree Required in Computer Science or Information Technology Management or Data Science.

• • Works as part of a team performing standard engineering work requiring application of standard engineering techniques, procedures and criteria.
  • Apply specialized theoretical knowledge in a creative way to a broad range of difficult problems.
  • Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with engineering staff, methods, techniques, theories, Corporate and division SOP’s, policies and projects.
  • Document development work including writing specifications for manufacturing or scientific test results.
  • Ability to solve routine design and engineering tasks with some assistance. Able to solve problems with periodic monitoring.
  • Assists in the preparation and participation in technical reviews and responsible for organizing data preparing appropriate documentation for assigned projects
  • Develop products/ processes (design, research techniques, etc) incorporating multiple tasks within area of expertise.
  •  Complete complex design and technical tasks, integrating information from a variety of disciplines.
  • Provide technical input to strategic plan
  • Incorporate Knowledge of customer use and product design to predict product effectiveness/ anticipate potential failures.
  • Utilize engineering tools to solve straightforward problems (e.g. FMEA, Finite Element Analysis, process Molding, Design of experiments, Mold flow, SPC 
  •  Lead project teams and laboratory activities as needed to accomplish project objectives.

Bachelors degree required in Mechanical Engineering or Biomedical Engineering or Biochemical Engineering

Mechanical Engineer needed to perform the following Job duties :

•  Providing support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
•  Resolving identified supplier issues and executing the overall project technical file remediation requirements and supporting project deliverables.
•  Working with Suppliers to meet EU MDR requirements and resolve issues with related to Supplier Product information.
• Supporting review and Approval EU MDR Change Projects as applicable and Supplier Quality Functional Impact Assessments as applicable.
•  Review and approving the design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Supporting risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary report.
•  Review and approve verification and validation activities drawing updates, labeling updates and including design impact assessments as required.
•  Applying statistical methods and design/process excellence tools to support design engineering rntinnnIe.s/memn.s a.s requirem.
• Assess MPI and supplier drawings and process information to support project deliverables.
•  Manufacturing Process Information, Production risk management file, Validation protocols and reports and Direct part marking documentation.
• Working with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities.
•  Support Review and Approval of supplier Process Validation Protocols and Reports as applicable and update of supplier related Inspection Criteria as applicable.
•  Provide leadership   in all areas of the Quality System,   including,   but   not limited   to   corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.

Bachelor’s Degree Required in Mechanical Engineering or Mechanical Engineering Technology .

•  Perform Risk Analysis, Root Cause Analysis, and Failure Analysis.
• Establish quality plans for products, quality reporting, Statistical Process Control (SPC) data analysis and the application of improvement tools in problem solving efforts.
• Coordinate the Offshore and onsite teams to ensure the Periodic Review of Documents is done per the site-specific procedure and timeline.
• Create and implement activities for support of quality in manufacturing areas for systems that are related to inspection and validation of protocols.
• Responsible for ensuring compliance with all the required procedures and establishing the inspection plan and methods for ensuring conformance to specifications. Responsible for revising standard procedures and protocols with revision summary.
• Implement new methods to improve the quality of products by improving manufacturing processes
• Develop measurement strategies to be used for measuring the parameters of a component, including the selection of sampling plan, deciding the Acceptable quality limits (AQL.
• Preparing Risk Assessment Worksheets, Non-Conformance Material Reports and Supplier Corrective Action and Preventive Action (SCAPA) Decision Trees.
•  Review and approve PPAP documents, supplier validation master plans and material testing requirements for quality assurance. Ensure that suppliers have necessary information and facilities to deliver quality products to client.
• Determine if the manufactured part meets the dimensional requirement specified in design documents like Design History File (DHF).
• Define critical features for inspection methods and sample size. The parts are visually inspected referencing prints to access the features that need inspection.

Bachelor’s Degree Required in Mechanical Engineering or Industrial Engineering or Engineering Technology or Industrial & Technical Studies or Industrial Management.

•  Ensure all CAPA requirements are met in each CAPA as part of the approval process.
•  Escalate identified event, trend, or other input for CAPA consideration.
•  Ensures overall execution of the CAPA in a timely manner, follows the CAPA Process, and documents and communicates results. This includes:
•  Coordinating and assigning CAPA failure investigation activities.
• Documenting the investigation summary and root cause(s) with rationale.
• Identifying Potential root causes are potential underlying causes for an undesirable condition or problem that has not yet occurred.
• Coordinating and assigning CAPA implementation activities with an owner and due date.
• Ensure CAPA reflects up-to-date information
• Coordinating and assigning CAPA effectiveness monitoring activities with an owner and due date.
• Conducting to determine assignable cause(s) or root cause(s) of an event or issue associated with a deficiency in a product, process, or quality system that fails to meet established specifications or requirements.
• Overseeing the CAPA activities to ensure that actions are completed appropriately and with appropriate objective evidence.
• Identify CAPAs that require periodic review, including risk re-assessment.
• Provide administrative support to CAPA process. Identify CAPAs that require periodic review, including risk re-assessment.
• Work with quality sub-system leaders to ensure that data analysis is documented and feeds into the CAPA system.

Bachelor’s degree in Industrial Management or related field

• Evaluated and completed non-conformance reports, product complaints, CAPA s and field actions and analyzed if they should be escalated    to a CAPA.

• Direct all phases of CAPA from initiation to closure.
• Ensures overall execution of the CAPA in a timely manner, follows the CAPA Process, and documents and communicates results which includes coordinating and assigning CAPA failure investigation activities, Ensure CAPA reflects up-to-date information.
• Assist with the investigation of Corrective and Preventive Actions (CAPA) to determinate the root causes (s) using fishbone diagram, 5 Whys, etc.
• Evaluate and complete non-conformance reports, product complaints, CAPA s and field actions and analyzed if they should be escalated to a CAPA.
• Schedule CAPA team meetings and ensured CAPA deliverables per project timelines.
•  Perform and documented timely Corrective and Preventive Actions (CAPA) investigations.
• Document associated with all phases of CAPA in compliance to 21CFR part 820.100 and ISO 13485.
• Driving timely execution of NCRa deliverables through monitoring and reporting status to NCR owners.
• Implementing current good manufacturing practices and providing training to assigned trainees about cGMP.
• Overseeing the CAPA activities to ensure the actions are completed appropriately and with appropriate objective evidence.
• Optimization of new and existing processes used for manufacturing medical device to meet specific clinical goals.
• Executing Gap and impact as part of procedures integration. 

Bachelors Degree: Industrial Engineering or related field of study. 

• Responsible for inventory requisition and conduct product inspections. Perform gauge
  inspection for the affected lot and prepare manufacturing process forms with the
  inspection results.
• Responsible for performing stock investigation and performing inspection activities.
• Responsible for requesting inventory of Biomet Affixus Nails as part of Product hold
  inspection. Recorded the inspection data through Manufacturing Process Forms (MPF)
  and released conforming parts.
• Perform Inspection on receiving First Article Samples (FAS) Parts with Best Fit gage pin.
• Responsible for Phoenix Nail inspection as a part of complaint triggered hold.
• Phoenix Trochanteric Nails will be inspected on a comparator for bend angle inspection.
• Report data through First Article Investigational Layouts and analyze data in comparison
  to actual print dimension.
• Phoenix Tibial Nails will be inspected for critical to Quality (CtQ) features on Coordinate
  Measuring Machine (CMM). Report data through First Article Investigational Layouts
  and analyze data in comparison to actual print dimension.
• Responsible for assuring products conform to established requirements and standards
  through appropriate audit, inspection, and test activities.
• Responsible for monitoring manufacturing technicians and ensuring production process
  for the current Work Instructions.
• Responsible for documenting Health Hazard and Issue evaluations on a regular basis for
  non-conforming products as part of continuous improvement.
• Perform evaluations and provide weekly updates on Health Hazard Evaluations and Issue
  Evaluations.
• Develop Receiving inspection criteria and sample plans with justification.
• Create/update Qcriteria and Icriteria for NPI projects and existing products.
• Responsible for reviewing prints. Identify critical personnel, gauges, procedures, and
  materials needed for the completion of new products.
• Review new launch bubble prints with basic knowledge in print reading. Verify for
  feature numbers, measurements, units, tolerance and format.
• Identify Critical to Quality features for Flush End caps, Tibial Nails, Retrograde Nails,
  Bone Screws, Cortical Nuts in Affixus Family as part of new product launch.
• Create Gauge overlays to inspect screw head and thread profile. Create Gage Usage
  Procedures (GUP) as needed.
• Generated First article layouts (FAL) for Medical Devices. Create FAL for ALPS
  Clavicle plates, Drill Guides, Soft Tissue Guides, Soft Tissue Handle, Depth gauge and
  many other implants & instruments which are part of New Product Introduction (NPI)
  projects.
• Collect and analyze data for gauge and product evaluation. Define critical features for
  inspection method and sample size.
• Assisted in supplier product testing. Worked with suppliers to get quality products on
  time.
• Review/ approve PPAP+ documents from vendors (defining requirements for qualifying
  production process with vendors).
• Identify the objective evidence requirements to support investigation and root cause
  conclusions. Identification of root cause and investigation results will be documented.
• Determine root cause and made corrective action recommendations as problems occur.
• Responsible for investigation of released product non-conformances (NCR’s), trend
  trigger events, and health hazard analysis in collaboration with other functions. Provide
  Quality record search analysis (QRSA) forms with the search parameters, methods and
  results on value-added trend data.
• Responsible to review Package inserts and PFMEA risk documents for risk assessments
  as part of design control risk management.
• Performed Health Hazard evaluations for Zimmer Natural Nails for BSI Tech File Audit
  Findings on missing evaluations of Magnetic Resonance Environments and risk of reuse
  in Package Inserts.
• Performed Evaluations for BSI Audit Findings on Dynafix VS Osteotomy System on
  missing MR Evaluations and Cleaning Validations.
•  Reviewed Design Failure Mode effect analysis (DFMEA) for Zimmer Plates and Screws.
• Updated new risk lines and formatted for appropriate procedure change. Provided
  rationale Memo for the changes made and routed the changes through change
  management system (CMS).
• Responsible for ensuring compliance with all appropriate procedures, establishing the
  inspection plan and methods for ensuring conformance to specifications.
• Responsible for evaluating corrective action and preventive action (CAPA) Records for completeness and accuracy. Perform Complaint–out-of-box (COOB) analysis, in search of affected lot.
• Collaborates with engineering and manufacturing functions to ensure quality standards
  are in place. Responsible for documenting Technical protocols and technical reports.
  Perform gage R&R, capability study and Attribute/Variable sampling plan acceptance
  criteria.
• Perform Unique Device Identification (UDI) Memo forms reviews.
• Perform industry standard capability study in Minitab for the inspection method to be
  acceptable. Released the Nails from hold worth $250,000~. Report the analysis through
  Technical Report.
• Develop cleaning cycle protocol and testing report using FDA Standard worst case
  scenario cleaning parameters.
• Develop sterilization protocol and testing report using FDA standard worst case scenario
  sterilization parameters.
• Complete trainings that are assigned on a weekly basis depending on the assigned work
  and scheduled tasks.
• Complete training forms as a proof of completion.
• Provide updates and feedback on new revisions. Perform tasks per the current training
  procedures and standards.
• Attend Introductory Print Reading and GD&T Training.

Bachelor’s degree: Industrial Engineering or related field.

• Write Impact assessment of the given equipment that uses the failure mode and effect analysis (FMEA) approach to assess the potential impact of residues that may reside on equipment used to manufacture components.
• Evaluate the cleaning validation, facilities/ utilities qualification, equipment qualifications and Test method validation records to ensure compliance with FDA regulations and current procedures.

• Extensively involved in the cleaning validation projects in a consent decree environment for facility certification.

• Author, review and approve cleaning validation technical reports, protocols, validation master plans and batch records for production equipment and processes.

• Identify deviations from established product or process standards and provide recommendations for resolving deviations.

• Ensure that validation records are accurate, complete with the corresponding objective evidence to support the validation performed

• Make recommendations to solve quality issue found in validation records.

• Perform characterization study for the existing cleaning process.

• Calculate and set the equipment acceptable limits for the equipment

• Train line operators to identify conforming / non-conforming product.

Calculate and set the Acceptable level for the given equipment based on the dimensions and the median Lethal dose 50 (LD50) value of the potential residues identified in the volume and on the surface of the equipment.

Bachelor’s degree:Mechanical Engineering or related field.

• Responsible for all aspects of Quality Assurance activities for compliance to company standards.
• Participation in the development and maintenance Corrective Action / Preventive Action, Non-Conformance Reports, Checklists, SOPs and Work Instructions.
• Perform Risk Analysis, Root Cause Analysis, and Failure Analysis.
• Provided gap assessments, problem statements, containment activities, root cause analysis, corrective action plans for several major findings within the company’s quality audit.
• Support the onsite Integration to Johnson & Johnson Standards, which include providing gap assessments, impact assessments, updating/obsoleting current onsite SOP’s and Work Instructions.
• Responsible for ensuring compliance with all the required procedures and establishing the inspection plan and methods for ensuring conformance to specifications. Responsible for revising standard procedures and protocols with revision summary.
• Coordinate the Offshore and onsite teams to ensure the Periodic Review of Documents is done per the site-specific procedure and timeline.
• Provide support to CAPA process. Identify CAPAs that require periodic review, including risk re-assessment.
• Compiled NCR’s appropriately when needed and identify the need to initiate CAPA.
• Identify and escalate trends or other input for CAPA consideration.
• Facilitate Documents for onsite audits.

• Generate and review NCRs (Non-Conforming Reports) using TrackWise to reduce deviations from company process & work with cross functional teams to investigate and resolve non- conformance.
• Analyze and write investigations to non-conformances and identify failure modes and determine root causes when possible.
• Investigate reported complaint events to conform non-conformances and to identify failure modes and determine root cause
• Manage, coordinate, review and approve Non-Conformances for robustness, accuracy and timely completion.
• Ensure investigation are clearly documented with appropriate objective evidence.
• Responsible for developing adequate root cause and developing corrective and preventive measures to prevent reoccurrence and/or eliminate issues.
• Determine quality improvement methods relevant to manufacturing processes and Identify non conformances trends to develop, administer technical investigation and corrective action programs to resolve recurring quality problems.
• Provide support to LEAN manufacturing culture operations to ensure products are manufactured to meet quality, reliability and cost requirements.  
• Apply statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Review Packaging Bill of Materials (BOM) for new products and coordinate with Team members on Quality related issues.   

• Identify and review Part Qualification documents such as First Article Inspection, Gage R&R, Process Failure Mode Effect Analysis, capability study, control plan, process validation etc.
• Develop requirements for quality inspection of incoming material from supplier.
• Conduct supplier audits and manage audit corrections.
• Facilitate the completion of Supplier Corrective Action Request and Vendor Quality Notices from supplier.  Perform activities to build Design History File and Device Master Record documents.
• Perform gap analysis to update procedures and documentation to meet the new European Medical Device Regulation.
• Conduct DFx reviews with external suppliers.
• Perform manufacturing line 5S reviews.
• Participate in Root cause investigations. Identify and Mitigate Quality Risk inside plant.
• Participate in engineering design reviews and provide inputs.
• Review and disposition product design and manufacturing process changes orders.
• Perform manufacturing area audit to review compliance to FDA 21 CFR Part 820 regulation.
• And any additional duties as deemed necessary for the project.

• Reviewing Design History Files, technical files and doing a gap assessment to find any
  discrepancies between the new and old regulations for the Chinese FDA and European
  Union Medical Device Regulations (EU MDR)
• Preparing submissions to renew ISO 13485- Quality Management Certificate to BSI for
  Europe.
• Reviewing and verifying Product Testing Reports (PTRs), product drawings, material
  specifications to ensure that they meet the current Chinese FDA regulatory requirements
  and resolving any found discrepancies.
• Assisting in successful implementation of the European Medical Device Regulations as
  per the revised EU MDR 2017/245 to ensure compliance and timely documentation for
  regulatory filing.
• Preparing for EU submissions as per the revised MDR guidelines and working on
  Technical files for Class I sterile, Class I non-sterile, Class I reusable, Class I measuring,
• Class IIa, Class IIb and Class III medical devices to ensure timely submission of the
  technical file.
• Revising and updating the Declaration of Conformity (DoCs) for respective technical
  files and design dossiers and ensuring that it represents all the current standards and
  regulatory requirements applicable to the respective medical device as per the revised EU
  MDR.
• Supporting the review of product labeling for medical devices and assisting in
  maintaining the current labels as required by the new EU MDR.
• Making technical files that are currently compliant with MDD 93/42/EEC in accordance
  with the new MDR (2017/245) by using the General Safety and Performance requirements(GSPR) and ensuring that all the changes required as per the new regulation
  are fulfilled technical files are submitted to BSI by the required timeframe.
• Assisting in dossier preparations for product registration submission to Chinese FDA.

Bachelor’s degree: Regulatory Affairs for Drugs, Biologics, and Medical
Devices.

Risk Management Quality Engineer needed to perform the following Job duties : 

• Execute and support on-time completion of Risk Management Deliverables
• Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
• Support Risk Management / Cybersecurity activities from product Concept through product obsolescence.
• Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.
• Complete Document Change Request Reviews in a timely and objective manner
• Additional duties may be identified by functional management based on the current project/business objectives.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Performs other related duties and responsibilities, on occasion, as assigned.

Bachelor’s Degree Required in   Mechanical Engineering or Industrial Engineering or Industrial Management.  

• Proactively identify Supplier quality issues, their causes and viable solutions.
• Effectively and collaboratively implement corrective actions to reduce and/or eliminate future occurrence.
• Interpret and implement ISO9000/13485 and FDA standards.
• Ensure corrective and preventive measures meet acceptable standards of robustness and effectiveness. Resolve components/material failures and focus actions on the root cause.
• Assure compliance to procedures and timely completion of SCAPAs and audit findings.
• Investigate and report corrective action effectiveness and timeliness.
• Support product continuation by assuring the quality of the components used in manufacturing and working supplier/component quality related issues to resolution.
• Manage supplier risks to prevent acceptance of sub-standard products.
• Implement supplier process controls and auditing strategies.
• Drafting documents for existing and new suppliers for the remediation procedure.
• Accessing SAP for pre-production sourcing data (purchase history).
• Working in parallel with suppliers and other cross functional team on any non- conformances that occur during production.
• Review and approve changes to purchased materials used in production.
• Ensure compliance of suppliers through leading and participating in supplier audits.
• Assure quality systems of OEMs, contract manufacturers and suppliers are maintained, and acceptance criteria are in alignment with component/product use and customer expectations. Develop and maintain Quality Agreements with suppliers.
• Develop qualification/validation plans and reports to assure components, materials and suppliers meet specified requirements and performance goals.
• Communicate and facilitate technical objectives between Customer and supplier.
• Develop and maintain inspection procedures for components and materials to support receiving inspection.
• Performing Capability Analysis (CpK, Normality, T-Test,) utilizing Minitab.
• Support and/or lead teams that develop new materials or implement significant supply chain changes.
• Participate in component and process Risk Assessments at suppliers.
• Promote continuous improvement using tools such as Lean, Six Sigma and Kaizen.
• Prepare and report supplier performance metrics (QMR, NCMR Reduction)

Degree requirement: Bachelor degree in Industrial Management or closely related field

CSupplier Quality Engineer needed to perform the following Job duties :

• Demonstrate knowledge of domestic and international requirements and standards such as FDA QSR Part 820, ISO 14971, ISO 13485, ISO 9001
• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Provides technical support for the introduction of components from a new supplier
• Assure quality systems of OEMs, contract manufacturers and suppliers are maintained, and acceptance criteria are in alignment with component/ product use and customer expectations.
• Generate and maintain incoming inspection procedures.
• Assist in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Participate in Component Qualification activities for New Product Implementation with existing and new suppliers.
• Analyze incoming material defects. Communicate Non- Conformance Issues with Suppliers.
• Develop qualification/ validation plans and reports of electronic components to assure components, materials and suppliers meet specified requirements and performance goals.
• Issue Supplier Corrective and Preventive actions as needed and review all investigative analysis from Supplier.
• Conduct root cause analysis activities in order to understand and resolve product and process issues.
• Investigate field failures related to supplier materials. Develop corrective action plan where necessary.
• Qualification of new suppliers and support of supplier/material changes
• Establish quality agreements with critical suppliers
• Manage the supplier change notification process, determine required actions for supplier changes, route to responsible subject matter experts, and assure change assessments are properly documented.
• Promote continuous improvement using tools such as Lean. Six Sigma and Kaizen.
• Support Material Review Board (MRB) evaluations of material deficiencies
• Manage the Supplier Corrective Action Request (SCAR) system
• Maintain the approved supplier list (ASL)
• Develop reports based on specifications using MATLAB.
• SAP ERP access to perform sourcing actions and purchase history for Supplier Segmentation Remediation.
• Maintain supplier documentation and files
• Provide quality systems input to suppliers such as, but not limited to: statistical process control, gage R&R studies, and capability studies
• Own supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
• Implement Production Part Approval Process (PAPP).
• Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies.
• Review and audit the deliverables including: Control Plans, Capability Plans, Capability Studies, Part layouts, Gage design, Gage R&R, PFMEA, DFMEA.
• Demonstrate a fundamental base in statistics, SPC, and process control methodologies.

Bachelor’s Degree required in Mechanical Engineering or Industrial Engineering or Engineering Technology or Industrial Management. 

Supports and/or creates Quality Engineering documentation such as Quality Plan, Validation Master Plans and Reports.

• Participates in development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
• Provides project with guidance on sound design control strategy compliant with Quality System Regulations (QSR) and Quality Management Systems (QMS), supporting a product release that is safe and effective, meets intended use, and is sustainable in the field.
• Understands and applies the manufacturing quality toolset including NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
• Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer.
• Attends and guides product risk assessments, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
• Works with product support teams, engineering and others on component quality issues and supplier initiatives.
• Attends meetings and work effectively with extended teams which may include Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing

Bachelor’s Degree required in Mechanical Engineering or Industrial Engineering or Engineering Technology or Industrial Management .

Sr. Regulatory Affairs Specialist needed to perform the following job duties:

• Supporting China TRD Remediation as business unit lead working with and communicating with China RA team and collaborating with local cross function team.
• Supporting Global requests from RA affiliates to support re-registrations.
• Updating Technical Files and appropriate filing.
• Compile 510(K) and Post Market Approval (PMA) submission  supplements and annual reports to maintain commercial approvals in the USA.
• Compile original Technical Files and Design Dossier submissions seeking commercial approval of unapproved assigned product lines in the European Union.
• Provide ongoing support to various cross-functional teams in their requests from regulatory affairs on manufacturing changes and the regulatory submission implications.

Bachelor’s degree required in Chemistry or Regulatory Affairs or Biology or PharmD.

• Conduct user interviews, gathered requirements and analyzed the requirements.  
• Create the Business Requirement Specification (BRS) and Functional Requirement (FRS) document for the system integration.
• Produce, update, and maintain documentation including project plans and weekly status.
• Prepare Verification & Validation Plan, aligned with business goals, defined, and prepared test cases and functional Verification & Validation test protocols.
• Prepare Analysis document to identify the individual application impact on the instrument.  
• Coordinate the implementation or scheduling of validation testing.
• Generate test cases from requirements documents for medical instruments.  
• Design the business requirement collection approach based on the project scope and SDLC methodology.
• Design and develop Uses Cases & Create the Verification & Validation Protocols for the required modules in the project.  
• Create the Requirement Traceability Matrix for the Test Case tracking.
• Execute test cases and generate execution reports.
• Documenting requirements for evidence gathering necessary for FDA 510K submissions.
• Implement of 21 CFR Part 820 – Quality System Regulations and IEC 62304.
• Conduct workflow, process diagram, and GAP analysis to derive requirements for existing systems enhancements.
• Determine and develop test strategies for Functional Verification and User Acceptance testing. 

• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
• Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
• Revise, review and approve verification and validation activities as required.
• Review and approve any required drawing updates, including design impact assessments.
• Review and approve any labeling updates, including design impact assessments.
• Deliverables to be quarterly based on assigned files.
• Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Ability to work in a team setting within Design Quality and cross-functionally is required.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development,
• Regulatory, Medical Affairs, Manufacturing, and Marketing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Report task progress and status on a weekly basis.

• Assess, collaborate and provide recommendations to the Firm's IT knowledge-base, training materials, best-practice, quick referencing guides and other internal communications.
• Lead and implement the provision of IT support services for attorneys and staff, including the reinforcement and advancement of the firms technologies, application systems, best-practices, knowledge bases and education opportunities.
• Work with office and IT leadership to develop business continuity planning, coordinating with other groups as necessary.
• Lead the team in resolving IT issues and delivering technical/operational enhancements in a complete and timely manner.
• Manage IT assets including planning, budgeting, acquiring, deploying and maintaining in accordance with IT policies.
• Responsible for coaching, business process engineering and problem solving.
• Knowledge and experience of Azure Cloud Platform, Office 365 cloud productivity suite, as well as Firewalls, security technologies, help-desk management, networking and associated infrastructure such as routers and switches are essential
• Cloud platform management, Office 365 administration, Virtualisation, Network and Security Architecture experience is also essential

• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
• Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
• Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary
• Revise, review and approve verification and validation activities as required.
• Review and approve any required drawing updates, including design impact assessments.
• Review and approve any labeling updates, including design impact assessments.
• Deliverables to be quarterly based on assigned files.
• Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support f
• Provide leadership in the understanding of medical device regulations to other discipline
• Ability to work in a team setting within Design Quality and cross-functionally is required.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Report task progress and status on a weekly basis.

• Review and assess the completeness of the internal and supplier’s First Article Inspection (FAI) requirements against the product specification and drawings requirements.
• Responsible for conducting gap analysis of the products to align with current regulations. Reviewing and updating existing procedures, part qualification documents, supplier qualification documents with respect to FDA regulations.
• Develop inspection plans incorporating the implementation of statistical sampling plans and tools for medical devices like patient monitors, defibrillators, aspirators, and vials to ensure materials conform to specified requirements.
• Performing root cause analysis, taking corrective actions, containment activities for several major finding while internal quality audits (CFR 820.22 and ISO 13485), CAPA (21CFR 820.100), NCR (21CFR 820.90) procedures.
• Review Incoming Inspection data to ensure received product manufactured according to specifications pertaining to functionality and safety of patient.
• Coordinate with suppliers in completing failure investigations to identify the potential root causes of the nonconformance and escalating the non-conformance and gap analysis results with supplier and other cross function team to have appropriate and cost-effective solutions.
• Evaluate the need for process improvement based on the Nonconformance data. Analyze the complaints file to identify the top defective parts and evaluate actions required to eliminate those defective parts.
• Performing Gage R&Rs on modified test methods and analyze the data for conformance with the applicable requirements and specifications using tools like MS Excel & Minitab.
• Initiate Engineering change orders (ECO) to implement the changes required for implementing the correct inspection requirements for the medical devices.
• Identify CTQ (Critical to Quality) characteristics and create Quality plans to determine COC (Certificate of Conformance)/ COA (Certificate of Analysis) requirements.
• Author, approve and audit the controlled documents based on 21 CFR Part 820 guidelines. Review the risk management of the product using ISO 13485 & 14971 guidelines.
• Periodically review issues by tracking database to verify issues are being resolved and closed in a timely manner in accordance to corporate policies and FDA regulations.

• Review and assess the completeness of the internal and supplier’s First Article Inspection (FAI) requirements against the product specification and drawings requirements.
• Responsible for conducting gap analysis of the products to align with current regulations. Reviewing and updating existing procedures, part qualification documents, supplier qualification documents with respect to FDA regulations.
• Develop inspection plans incorporating the implementation of statistical sampling plans and tools for medical devices like patient monitors, defibrillators, aspirators, and vials to ensure materials conform to specified requirements.
• Performing root cause analysis, taking corrective actions, containment activities for several major finding while internal quality audits (CFR 820.22 and ISO 13485), CAPA (21CFR 820.100), NCR (21CFR 820.90) procedures.
• Review Incoming Inspection data to ensure received product manufactured according to specifications pertaining to functionality and safety of patient.
• Coordinate with suppliers in completing failure investigations to identify the potential root causes of the nonconformance and escalating the non-conformance and gap analysis results with supplier and other cross function team to have appropriate and cost-effective solutions.
• Evaluate the need for process improvement based on the Nonconformance data. Analyze the complaints file to identify the top defective parts and evaluate actions required to eliminate those defective parts.
• Performing Gage R&Rs on modified test methods and analyze the data for conformance with the applicable requirements and specifications using tools like MS Excel & Minitab.
• Initiate Engineering change orders (ECO) to implement the changes required for implementing the correct inspection requirements for the medical devices.
• Identify CTQ (Critical to Quality) characteristics and create Quality plans to determine COC (Certificate of Conformance)/ COA (Certificate of Analysis) requirements.
• Author, approve and audit the controlled documents based on 21 CFR Part 820 guidelines. Review the risk management of the product using ISO 13485 & 14971 guidelines.
• Periodically review issues by tracking database to verify issues are being resolved and closed in a timely manner in accordance to corporate policies and FDA regulations.

• Develop validation and quality assurance documents including templates for validation related documentation such as Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Review Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP Analysis
• Develop detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS)
• Develop Test Plan, Test Cases, Test Script, and Test Result Report for Manual as well as Automatic Testing
• Documentation of various stages of validation lifecycle, in accordance with FDA 21 CFR Part 11 and 820 regulation.
• Develops and approves quality system documentation such as standard operating procedures and work
• Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
• Supports, leads in the development and executes process validation protocols, FMEAs, quality plans, inspections (control) plans and specifications.
• Provide technical quality support and documentation for pilot production, validation and verification builds.
• Participate in and lead, when assigned, process improvement teams working with cross functional team members to meet business objectives.
• Prepare Validation Master Plans (VMP) for validating analytical laboratory equipment
• Work on validation for lab equipment including GC, HPLC, Spectrophotometer (FT-IR, MS, UV-Vis), Autoclaves, Ovens, Incubators, labeling systems, Calibration software (preferably Maximo), Freeze dryer systems in compliance with standard guidelines and regulations
• Play a major role in performing Part 11 assessment, especially contributing to the components involved in maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR Part 11 regulations
• Assist to ensure audit readiness of the validated systems
• Assist in activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control and remediation
• Support risk assessment and system lifecycle processes such as change control and document management
• Contribute to systems validation in a regulatory environment, including systems, but not limited to process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, or quality systems
• Proactively escalated issues and risks appropriately through proper channels
• Involve in deficiency investigations, reviewing and preparing SOPs and quality system development
• Design and write training manual template and were involved in project planning.

• Update the Redlines for Design Control documents, provide feedback and recommendation for identified issues.
• Review and assess the complete DHF for various product line and device history file documents for planning.
• Review primary missing documents for Design Input and Design Output, Design Product requirements, Design Customer requirements and Applicable standards/ Essential requirements.
• Verify Design History File (DHF) deliverables, review the deliverables and perform GAP analysis.
• Provide input for changes in the Design Customer requirements.
• Update the Design Customer requirements procedures to ensure compliance with 21 CFR820, ISO 10993, International and FDA regulatory and safety standards.
• Evaluate and implement changes for the Design Input/Design Output documents.
• Create Work Instructions, update SOPs and ensure compliance with the governing rules and regulations
• Enhanced ability to implement projects and compliance programs, understand policies and procedures and governing compliance requirements for medical devices.

• Updated the Design Control procedures to ensure compliance with 21 CFR 820.

• Participated in product development team meetings, representing Quality.
• Performed risk evaluation of findings to define criticality and prioritize remediation activities.
• Tracked and maintained compliance records and documents
• Reviewed documents, including Risk Analysis, FMEA, Technical Reports, product labeling and marketing literature.
• Performed assessments on previously validated Design Verification and Validation documents.
• Set up design and development process as per 21 CFR 820.30, ISO13485 and ISO 10993 requirements
• Work with the SMEs and internal and external Reviewers to identify gaps and mitigate the risks
• Performed risk evaluation of findings to define criticality and prioritize remediation activities.