$155,000 – $175,000
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 leads quality management and regulatory compliance for a life sciences manufacturing site, overseeing quality assurance, control, and laboratory functions. It suits experienced quality professionals with deep knowledge of FDA regulations and ISO standards who want to drive operational excellence in a regulated biotech environment.
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
- Bachelor's degree in Science or Engineering, or 10+ years equivalent regulated manufacturing experience
- At least 7 years quality, quality engineering, or manufacturing operations experience in life sciences, biotech, medical device, biopharma, or FDA/EPA-regulated environments
- Minimum 5 years leadership experience
- Strong knowledge of ISO 9001, ISO 13485, FDA regulations, cGMPs, and CFR requirements
- Proficiency in quality statistical methods, Lean Manufacturing, and Six Sigma
- Proven ability to lead, coach, and mentor teams
- Budget management and strategic operational skills
- Ability to travel 10% of the time
- Physical capability to access equipment up to 5-6 feet high and lift 20-35 lb parcels
Nice to have
- 2+ years leading both Quality Engineering and Quality Laboratory
- Analytical chemistry or microbiology experience in ISO 17025 environment
- Contamination control, sterilization, sanitation, or E-beam experience with ISO 14644 knowledge
- Experience with SAP, Oracle, VEEVA, or Magic systems