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Sr. Design Quality Engineer

Company: Katalyst Healthcares & Life Sciences
Location: Mahwah
Posted on: November 24, 2022

Job Description:


  • Reviewing and maintenance of risk management files, including risk analysis documentation
  • Reviewing of test protocols to ensure compliance with QMS processes, with sufficient statistical justification for sampling and acceptance criteria
  • Ensuring compliance of design controls per regulations and internal process requirements
  • Reviewing sampling plans for adequacy by applying attribute, variable, and sequential sampling methods


    • 7+ years of work experience in the Medical Devices experience, primarily in Design & Quality Engineering
    • Bachelor's degree in engineering or other technical discipline
    • Experience with product development life cycle, design and development, risk management, and design/process verification/validation
    • Ability to perform and review risk analysis tools (FMEAs, Hazard Traceability Matrices)
    • Ability to review and perform Root Cause Analysis
    • The soft skills to be the sole representative of quality in engineering meetings, being the voice of the design quality initiatives

Keywords: Katalyst Healthcares & Life Sciences, Paterson , Sr. Design Quality Engineer, Engineering , Mahwah, New Jersey

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