Supplier Quality Engineer - Medical Devices

About the role

Jabil is looking for a detail-oriented Supplier Quality Engineer (SQE) with experience in the medical device, healthcare products or pharmaceutical industry. The role ensures the quality, compliance and performance of suppliers throughout the supply chain, covering supplier qualification, audits, quality improvement, incoming quality and regulatory compliance (ISO 13485, FDA 21 CFR Part 820, ISO 14971, GMP). It also includes supporting the Quality Management System (CAPA, internal audits, DHF/DMR/DHR review).

Key responsibilities

• Lead supplier qualification, approval and onboarding, and set up supplier quality agreements and approved supplier lists.
• Plan and run supplier audits, track findings and close corrective actions; support regulatory and external audits.
• Investigate SCARs with root cause analysis (5 Whys, Fishbone, Fault Tree) and verify corrective and preventive actions.
• Manage incoming quality, non-conformances and supplier complaints, and drive defect reduction.
• Support NPI by reviewing supplier process validation and readiness for new products and engineering changes.
• Take part in supplier risk management (ISO 14971), PFMEA/DFMEA and change control (IQ/OQ/PQ, supplier change notifications).
• Run supplier quality improvement initiatives (Lean, Six Sigma) and maintain quality records and documentation.
• Support the QMS: CAPA investigations, internal and supplier audits, design documentation review, NCR handling and validation support.

Required profile

• Bachelor's degree in Engineering, Biomedical, Manufacturing, Quality or Life Sciences engineering.
• 3-8 years of experience in supplier quality, quality engineering or supplier development in medical devices, electronics manufacturing or pharmaceuticals.
• Office and manufacturing floor interaction, domestic and international travel for supplier audits and qualification visits, and participation in regulatory inspections.

Required skills

• ISO 13485, FDA 21 CFR Part 820, ISO 14971 and GMP
• Supplier audits, supplier qualification and corrective action management
• Quality tools: CAPA, 8D, 5 Whys, Fishbone, FMEA, Six Sigma
• Preferred: ASQ CQE, Six Sigma Green/Black Belt, Class II/III devices, sterile products, eQMS, CMO, SMT and HLA experience, CE marking and FDA 510(k)