Sr Manager, Product Quality

Thermo Fisher Scientific UK

10+ years quality assurance management experience
Iso 9001, ce-ivd 13485, gmp 21cfr820 knowledge
Leadership in highly regulated medical device industry
The Sr Manager will lead the Product Quality function across all sites and suppliers for the Life Science Mass Spectrometry Business Unit

Job Summary

  • The Sr Manager will lead the Product Quality function across all sites and suppliers for the Life Science Mass Spectrometry Business Unit.
  • This role requires fostering a quality culture through measurable metrics while managing warranty cost reduction initiatives alongside service and product support teams.
  • Candidates must demonstrate strong leadership capabilities to hire, develop, and coach quality personnel while ensuring compliance with ISO, CE-IVD, and GMP standards.

Matching Summary

The Sr Manager will lead the Product Quality function across all sites and suppliers for the Life Science Mass Spectrometry Business Unit.

Skills & Requirements

Must-have

  • 10+ years Quality Assurance management experience
  • ISO 9001, CE-IVD 13485, GMP 21CFR820 knowledge
  • Leadership in highly regulated medical device industry
  • Experience with 8D, FMEA, SPC, and validation processes
  • Bachelor's degree in engineering or scientific discipline

Nice-to-have

  • MBA or advanced engineering/scientific degree preferred
  • Startup environment experience is a plus
  • Six Sigma or TQM manufacturing background
  • Strong ability to drive culture change
  • Experience with international multicultural teams

Key Requirements

  • Minimum 10 years QA management experience
  • Minimum 3 years Quality Leadership in medical device sector
  • Bachelor's degree required; MBA preferred
  • Fluent English communication skills required
  • Ability to travel up to 25%

Work Rights

Not specified

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