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Quality Engineering Regulatory Compliance Specialist Biomedical Engineer

Senior Quality Engineer

Job in Minneapolis, Hennepin County, Minnesota, 55443, USA
Listing for: Katalyst Healthcares & Life Sciences
Full Time position
Listed on 2026-09-01
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer
Job Description & How to Apply Below

Senior Quality Engineer

We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. Roles & Responsibilities:

  • 10+ years of Quality Engineering experience in medical device manufacturing.
  • Strong experience with FDA-regulated environments & Quality Systems.
  • Hands-on Technology/Product/Process/Manufacturing Transfers.
  • Validation experience: IQ/OQ/PQ, TMV & Process Validation.
  • FDA-compliant quality documentation.
  • PFMEA, Control Plans, Nonconformance & CAPA.
  • Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management.
  • Customer complaint investigations & Root Cause Analysis.
  • Manufacturing readiness, NPI & scale-up.
  • Strong technical writing and documentation skills.
  • Internal/external audit support preferred.
  • Injection molding, assembly or contract manufacturing experience is a plus.
    • Position Requirements
    10+ Years work experience
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