Director, Quality Engineering - San Francisco
1 month ago
Job Summary
The Director Quality Engineering will lead and strategically direct the quality engineering function ensuring the design development and manufacturing of medical devices meet the highest standards of safety efficacy and regulatory complianceThis role is crucial in driving a culture of quality throughout the product lifecycle
Qualifications
- Bachelor s degree in Engineering e.g Biomedical Mechanical Electrical Industrial or a related scientific discipline required Master s degree preferred
- Minimum of 10 years of progressive experience in Quality Engineering within the medical device industry with at least 5 years in a leadership or management role
- In-depth knowledge of medical device regulations and standards including FDA CFR Part ISO ISO
and relevant international regulations - Proficiency in quality tools methodologies such as FMEA SPC MSA Root Cause Analysis CAPA statistical techniques
- Proven ability to lead motivate and develop high-performing teams Excellent interpersonal communication skills written verbal Strong analytical problem-solving skills with data-driven decision-making Certifications ASQ certifications such as Certified Quality Engineer CQE Certified Quality Manager CQM OE Six Sigma Black Belt Technical Acumen Strong understanding of medical device design manufacturing processes associated quality challenges
Job description
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