Senior Quality Assurance Engineer Cepheid San Jose
Overview
Drive accelerated innovation in life sciences diagnostics by leading quality engineering for medical device manufacturing. You will own day-to-day quality support overseeing plastic part design and manufacturing equipment while serving as primary representative on cross-functional teams for new product introduction. This role delivers measurable impact globally through rigorous compliance with ISO 13485 and 21 CFR 820 while fostering continuous improvement.
What You'll Do8
- 1Lead quality engineering support for medical device manufacturing including oversight of plastic part design and manufacturing equipment performance
- 2Serve as primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment
- 3Drive risk assessment activities including safety design and process FMEA with focus on quality requirement interpretation and verification/validation planning
- 4Develop and review project documentation such as quality plans validation master plans risk management plans and IQ/OQ/PQ/PV protocols
- 5Address nonconformities by performing root cause analysis conducting failure mode analysis and supporting corrective preventive actions
- 6Travel domestically and internationally for up to 10% of time while maintaining physical environment standards
- 7Maintain detailed records of quality deliverables throughout design transfer to manufacturing
- 8Collaborate with engineering teams to ensure accurate documentation for design control and risk management initiatives
Requirements5
- 1BS degree in mechanical industrial biomedical engineering or related field with 5+ years quality engineering experience
- 2Strong understanding of ISO 13485 21 CFR 820 and GMP requirements
- 3Proven experience in NPI Quality with complex systems including design verification validation part and process qualification
- 4Travel ability for up to 10% of time
- 5Certified Quality Engineer Lead Auditor certification preferred
Salary Insight
$116 - $160k per year
Location
Required Skills
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