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Beckman Coulter

Senior Quality Assurance Engineer

Beckman Coulter

full time · Senior

$116,000 – $159,500

Listed on Beckman Coulter’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This role develops quality systems and manages compliance for medical device manufacturing, ensuring products meet regulatory standards through design controls, risk assessment, and process validation. It suits experienced quality engineers who want to drive innovation in life sciences diagnostics while working on high-impact healthcare solutions.

Our summary, not Beckman Coulter’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • BS in mechanical, industrial, biomedical engineering or related field with 5+ years quality engineering experience, or MS with 3+ years quality experience
  • Understanding of ISO 13485, 21 CFR 820, and GMP requirements
  • Experience with NPI quality and complex systems including design verification/validation, part and process qualification, and equipment qualification
  • Domestic and international travel up to 10%

Nice to have

  • Medical device or pharmaceutical manufacturing experience
  • Certified Quality Engineer certification
  • Lead Auditor certification

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