Site Quality Head

Thermo Fisher Scientific UK

Ontario, Canada
Base: $133,600.00–$200,350.00; bonus/equity: not s...
Standard office job (mon-fri)
6+ years strategic quality leadership experience
5+ years site quality lead experience
Expertise in fda cfr 820 and iso 13485
Thermo Fisher Scientific is seeking a Site Quality Head for their Ontario location, responsible for leading quality assurance strategies and ensuring compliance within manufacturing sites. The ideal candidate will have extensive experience in quality leadership roles, particularly in regulated medical device or pharmaceutical manufacturing

Job Summary

  • This leadership role guides quality assurance strategy and develops a culture of excellence across manufacturing sites to ensure products meet the highest standards.
  • The position requires overseeing all QA activities, maintaining regulatory compliance with FDA and ISO standards, and collaborating to improve business outcomes.
  • Candidates will have the opportunity to build quality systems that support the mission of enabling customers to make the world healthier, cleaner, and safer.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Site Quality Head for their Ontario location, responsible for leading quality assurance strategies and ensuring compliance within manufacturing sites. The ideal candidate will have extensive experience in quality leadership roles, particularly in regulated medical device or pharmaceutical manufacturing.

Salary

Base: $133,600.00–$200,350.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 6+ years strategic quality leadership experience
  • 5+ years site quality lead experience
  • Expertise in FDA CFR 820 and ISO 13485
  • Proficiency in FMEA, SPC, and risk management
  • Experience leading teams of 8-10 direct reports

Nice-to-have

  • ASQ Quality Manager Certification preferred
  • Lean or Six Sigma improvement systems experience
  • Electromechanical manufacturing background preferred
  • Strong change management capabilities
  • Excellent communication and presentation skills

Key Requirements

  • Advanced Degree plus 6 years experience OR Bachelor's plus 8 years
  • Proven expertise in MDR and ISO 14971 risk management
  • Demonstrated ability to transition organizations from QC to QA
  • Experience managing external regulatory authority inspections
  • Ability to travel 25-30% of time

Work Rights

Not specified

Tailored Resume

Cover Letter