Manager Quality Assurance, Validation

Danaher / Beckman Coulter Diagnostics

Chaska, MN, US
Base: $130,000 to $160,000; bonus/equity: eligible...
Not specified (assumed on-site)
9+ years experience in quality systems
Medical device or pharmacy industry validation
21 cfr 820 and iso 13485 compliance
Beckman Coulter Diagnostics is seeking a Quality Assurance Manager for their Chaska, MN location, focusing on ensuring high-quality and compliant medical laboratory devices. The ideal candidate should possess extensive experience in quality systems, validation processes, and management within the diagnostics or pharmaceutical industry

Job Summary

  • This role manages professional associates and operation support to ensure delivery of high quality, reliable, and compliant medical laboratory devices.
  • The position requires deep understanding of Quality Systems, Process Validation, and Test method validation within the medical device industry.
  • Candidates will lead a team of seven or more while fostering a culture of belonging, diversity, and continuous improvement aligned with the Danaher Business System.

Matching Summary

Match Score: 85

Beckman Coulter Diagnostics is seeking a Quality Assurance Manager for their Chaska, MN location, focusing on ensuring high-quality and compliant medical laboratory devices. The ideal candidate should possess extensive experience in quality systems, validation processes, and management within the diagnostics or pharmaceutical industry.

Salary

Base: $130,000 to $160,000; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package including paid time off, medical/dental/vision insurance, and 401(k)

Skills & Requirements

Must-have

  • 9+ years experience in Quality Systems
  • Medical device or pharmacy industry validation
  • 21 CFR 820 and ISO 13485 compliance
  • Management of 7+ direct reports
  • Manufacturing process validation expertise

Nice-to-have

  • Lead Auditor Certification
  • Equipment lifecycle management experience
  • Non-product software validation background
  • Cost savings and supply continuity focus

Key Requirements

  • Bachelor's degree with 9+ years experience or Master's with 7+ years
  • Degree preferably in Chemistry, Biology, or similar scientific field
  • Previous management or project leadership experience required

Work Rights

Not specified

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