Sr. Supplier Development Engineer
On-site · Suzhou, Jiangsu, China
Job Summary
Senior-level lead auditor role focusing on external supplier audits for medical device components, products, and services. Responsibilities include planning and executing remote and on-site audits of supplier QMS against ISO 13485/ISO 9001, assessing core supplier processes (manufacturing controls, process validation, risk management, documentation, CAPA, design transfer), generating audit reports, driving corrective actions (SCARs/SQNs), and ensuring regulatory compliance. Travel 30-50% domestically and internationally. Requires Certified Lead Auditor certification (or equivalent internal program), formal ISO 13485 and ISO 9001 training, and 10+ years of experience in medical device/pharma-regulated manufacturing. Preference for additional standards (ISO 17025) and strong client-supplier relationship skills.
Required Qualifications
- Certified Lead Auditor through IRCA, RAB-QSA, ASQ, BSI, TÜV or completion of an approved internal Lead Auditor training program
- Formal training in ISO 13485 and ISO 9001 (minimum); additional standards such as ISO 17025 preferred
- Demonstrated experience conducting external supplier audits in the medical device, pharmaceutical, or regulated manufacturing industry
- Proficiency with audit management systems and documentation tools
- Travel to supplier sites up to 30-50% domestically and internationally
- Minimum education: Bachelor's or Master's Degree in Engineering, Science, or related field
- Strong communication, negotiation, and relationship-building skills
- Ability to work independently and manage multiple audits in parallel
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