About the role

  • Provide quality engineering support for manufacturing operations (in-house and contract manufacturing)
  • Establish and maintain robust in-process and final inspection criteria; support production ramp-up and continuous improvement
  • Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820
  • Develop and maintain the supplier quality program, including supplier selection, audits, qualification, and performance monitoring
  • Manage supplier non-conformances and corrective actions to ensure timely and effective resolution
  • Ensure compliance with design control requirements; author, review, and approve DHF, risk management files, and V&V protocols and reports
  • Support design transfer activities to manufacturing and collaborate cross-functionally on change control
  • Lead root cause investigations, implement CAPAs, and support internal and external audits and regulatory submissions

Requirements

  • 5+ years of quality or manufacturing engineering experience in medical devices
  • BS in Engineering (preferably Electrical, Mechanical or Biomedical)
  • Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601)
  • Strong interpersonal, and communication skills
  • ASQ CQE, or related certification a plus.

Job title

Senior Quality Engineer

Job type

Experience level

Senior

Salary

$140,000 - $160,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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