Description

• 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.