Manager, QA
Thermo Fisher Scientific · Fremont, CA
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Thermo Fisher Scientific seeks a Quality Engineering Manager in Fremont, CA to lead quality activities across product lifecycle, from design through post-market surveillance. The role provides technical direction to the Quality Engineering team while ensuring regulatory compliance and driving continuous improvement in a medical device manufacturing environment.
What they're looking for
- Leadership experience managing technical Quality Engineering teams
- Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and MDSAP regulations
- Expertise in design controls, new product introduction, and risk management
- Experience with nonconformance, deviation, and CAPA investigation processes
- Strong cross-functional collaboration and data-driven decision-making skills
- Medical device or life-science manufacturing quality background
What you'll be doing
- Lead, coach, and develop Quality Engineering team with performance accountability
- Provide technical oversight for design controls, NPI, and product/process risk assessments
- Direct investigations and resolution of nonconformances, deviations, CAPAs, and complaints
- Establish compliance procedures aligned with regulatory requirements and monitor metrics
- Drive cross-functional review meetings and continuous improvement initiatives
Privacy & handoff
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