Senior Design Quality Engineer

2 weeks ago

Washington Twp, United States Catalyst Life Sciences Full time

Joining an established & small Medical Device company, within quality team with both sustaining and new product activities in the pipeline, the Senior Design Assurance Engineer position will give someone the opportunity to lead and mentor quality members, and take the reigns on all design quality activities at a leadership level.

Main Responsibilities

  • 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

Experience Required

  • 5 years of work experience in the Medical Devices experience, primarily in Design & Quality Engineering
  • Bachelors 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)
  • The soft skills to be the sole representative of quality in engineering meetings, being the voice of the design quality initiatives
  • Ability to work on-site at least 3 days a week.

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