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.
Responsibilities
- 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
Requirements
- 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
Manager, QA in fremont at Unknown Company
This position is listed as full time and onsite.