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supplier audits process validation fmea iso 13485 eqms📋 Description
- Lead supplier selection, evaluation, and ASL maintenance
- Collaborate with suppliers on quality agreements and expectations
- Identify supplier risks; prevent/resolve issues impacting continuity
- Guide teams through FMEAs, validation plans, IQ/OQ/PQ
- Oversee supplier audits, qualifications, SCARs, NCRs
- Define KPIs and data systems for supplier quality
🎯 Requirements
- Bachelor's or Master's in Engineering (Biomedical/Mechanical/Electrical)
- 10+ years in quality engineering or medical device development
- FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1 knowledge
- Ability to travel up to 25%
- Experience in design transfers to manufacturing
- Hands-on risk management tools (FMEA, risk analysis)
🎁 Benefits
- Competitive compensation including stock options
- Comprehensive benefits package
- 401(k) with matching contributions
- Opportunity to work on cutting-edge projects to transform patients' lives
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