Quality Engineer

Designation: Engineer

Location: USA

Qualification: Bachelor’s Degree


  • 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.

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