Supplier Quality Engineer
On-siteBengaluru, Karnataka, India
Job Summary
Manage supplier evaluation, selection, and qualification processes in accordance with FDA 21 CFR Part 820, ISO 13485, and company-specific quality system requirements. Monitor supplier performance using scorecards, audits, and key metrics like PPM and CAPA closure rates. Draft, negotiate, and manage Supplier Quality Agreements while maintaining up-to-date documentation for internal and external audits. Support the issuance, investigation, and closure of SCARs by reviewing root cause analyses and corrective action plans. Remediate supplier records in SAP, ensuring all information is current, consistent, and audit-ready. Review supplier-submitted documentation including CoCs, PPAP, and FAIs, and support supplier-related sections of regulatory audits. Collaborate with cross-functional teams to address supplier issues and drive continuous improvement.
Required Qualifications
- Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline
- 5–7 years of relevant experience in Supplier Quality Engineering, preferably in the medical device or pharmaceutical industry
- Strong knowledge of ISO 13485, ISO 15378, FDA QSR, EU MDR, and supplier quality systems
- Demonstrated experience in managing Supplier Quality Agreements, SCARs, and conducting supplier audits
- Proficient in SAP and supplier data management
- Strong communication, negotiation, and cross-functional collaboration skills
- Working knowledge of GMP, GDP, and validation protocols
Desired Qualifications
- Certified Lead Auditor (ISO 13485 or ISO 9001) preferred
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