Development Quality Engineer # JN -062021-66386

Westford, Massachusetts
Industry: Database Administrator / Engineers
Job Number: JN -062021-66386

Title                           : Development Quality Engineer

Location                    : Westford, MA, 01886

Duration                   : 12 months contract



  • Bachelor level degree in an Engineering Discipline or other technical field experience


  • Participate in or lead teams in supporting quality disciplines, decisions, and practices
  • Lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects
  • Accountable for generation of PDP design verification test plans/reports for product/system requirements
  • Lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports
  • Completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments
  • Lead identification of essential outputs and generate Essential Output reports
  • Accountable for completion of labeling verification activities and labeling verification reports
  • Work with design engineering in the completion of customer/system/product requirements

·        Work with design engineering in the completion of product verification and validation

·        Endure DHF content completion, integrity and regulatory & standards compliance

·        Collaborative communication resolving gaps



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