Sr. Supplier Quality Engineer I (Contract Manufacturing)
$100,000–$123,000 year
Hybrid · San Diego, California, United States
Job Summary
Senior Supplier Quality Engineer I responsible for leading supplier audits, qualifying new suppliers, monitoring performance, and providing quality guidance for supplier management in a regulated medical device environment. Key activities include conducting audits (including 3rd party), managing CAPA and verification, drafting and revising Quality Agreements, overseeing supplier performance per approved processes, identifying process gaps, leading continuous improvement with suppliers/contract manufacturers, and applying quality tools (PFMEA/DOE/Lean) to ensure conformance of materials and components used in Tandem’s product operations.
Required Qualifications
- Bachelor’s degree in Engineering or related field
- Experience with supplier and contract manufacturers in regulated environments
- ISO 13485, ISO 14971, ISO 9001 knowledge
- QMS and process auditing
- GMP knowledge
- Statistical methods (sampling, capability, SPC)
- Problem solving (5-why, fault tree, DOE)
- GD&T understanding
- Experience with contract manufacturers and PCB/PCBA
- Medical device manufacturing or FDA-regulated industry experience preferred
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