Sr Supplier Quality Engineer

Main Responsibilities

1. Execute and lead supplier audits (on-site and remote) under ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.
2. Ensure proper implementation of APQP, PPAP, FMEA, Control Plans, and SPC at supplier sites.
3. Manage SCAR/CAPA processes with a strong focus on root cause analysis (8D, DMAIC, 5 Whys), ensuring effective closure and prevention of recurrence.
4. Validate critical supplier processes through IQ, OQ, and PQ, including special processes (molding, assembly, sterilization, etc.).
5. Monitor and improve supplier performance metrics (PPM, OTD, NCR, COPQ).
6. Lead Incoming Quality Control (IQC) activities and risk-based inspection plans (AQL, sampling plans).
7. Actively participate on the production floor to ensure proper material release, containment of nonconformities, and line support.
8. Manage engineering and supplier changes through Change Control processes (ECO/ECN).
9. Collaborate with Manufacturing, Engineering, and Procurement teams to ensure supply chain robustness.
10. Develop and qualify new suppliers, including process audits and capability assessments.
11. Ensure compliance with regulatory and customer requirements, including technical documentation, traceability, and validation.
12. Support internal, external, and regulatory audits (FDA, Notified Bodies), including preparation of objective evidence.