Senior Quality Assurance Engineer
Danaher · Sunnyvale, CA +1 more
The apply link worked recently (not employer-confirmed).
Role summary
Danaher's Cepheid division seeks a Senior Quality Assurance Engineer to oversee manufacturing and product lifecycle quality for molecular diagnostic systems. The role involves implementing risk-based quality strategies, managing new product introduction and change control processes, and ensuring compliance with FDA and ISO standards. The position, based in California, requires direct oversight of design, manufacturing operations, and cross-functional quality deliverables.
What they're looking for
- Bachelor's degree in mechanical, industrial, or biomedical engineering, or related field
- 5+ years of quality engineering experience, or master's degree with 3+ years
- Strong knowledge of ISO 13485, 21 CFR 820, and GMP requirements
- Proven experience in NPI quality and complex systems including design verification/validation
- Experience with part and process qualification and automation equipment qualification
- Ability to travel domestically and internationally up to 10% of the time
What you'll be doing
- Lead daily quality engineering support for medical device manufacturing operations and quality inspections
- Serve as primary quality representative on cross-functional teams for new product introduction and sustainment
- Drive risk assessment activities including safety and design FMEA with focus on compliance and problem resolution
- Develop and review project documentation including quality plans, validation protocols, and risk management plans
- Address nonconformities and deviations through risk assessment, root cause analysis, and corrective actions
Privacy & handoff
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