Supplier Quality Engineer Lead

Responsibilities

• Define and lead supplier quality strategy aligned with business objectives and regulatory requirements.
• Provide functional leadership and mentoring to Supplier Quality Engineers.
• Serve as escalation point for supplier quality issues, Risk 1 suppliers, outsourced processes, and supply chain disruptions.
• Influence senior leadership decisions related to supplier risk, sourcing strategy, and business continuity.
• Lead planning and execution of global supplier audit programs (onsite, remote, desktop).
• Ensure effective management, escalation, and closure of audit findings and compliance gaps.
• Act as primary Quality representative for supplier-related regulatory inspections, notified body audits, and health authority inquiries.
• Establish and oversee supplier risk classification, risk assessment, and mitigation frameworks.
• Review, trend, and present supplier performance metrics and risk data to Management Review and senior leadership.
• Ensure proactive identification of systemic supplier risks and continuous monitoring of supplier health.
• Provide oversight and escalation leadership for Supplier Corrective Action Requests (SCARs), ensuring robust root cause and sustained effectiveness.
• Lead supplier-related Nonconforming Material Reports (NCMRs) and support critical escalations.
• Evaluate and manage Supplier Change Notifications (SCNs) and change impact assessments.
• Lead supplier development initiatives focused on quality improvement, compliance, delivery performance, and resiliency.
• Support New Product Introduction (NPI), supplier transfers, localization, and dual-sourcing initiatives.
• Provide quality leadership for supplier-facing validation activities (IQ/OQ/PQ, PPAP, qualifications).
• Develop, maintain governance and continuous improvement of Supplier Quality Agreements, SOPs, workflows, and metrics.
• Ensure supplier documentation, records, and controls remain compliant with QMS and regulatory expectations.
• Drive cross-functional alignment across the supplier lifecycle from selection through post-market support.

Qualifications

• Expert knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.
• Strong leadership experience in supplier quality governance, audits, CAPA/SCAR, and risk management.
• Demonstrated ability to lead through influence and manage complex cross-functional initiatives.
• Advanced problem-solving and quality tool expertise (RCA, FMEA, statistical analysis).
• Executive-level communication skills with internal leadership and external suppliers.
• Proficiency with MS Office, Minitab, ERP systems, and eQMS platforms.
• 7+ years experience in Supplier/Vendor Quality Management.
• 10+ years experience in a regulated quality environment (medical device, pharma, life sciences).
• Proven leadership of high-risk suppliers, regulatory interactions, and global supplier initiatives.
• Bachelor's Degree in Chemical, Electro-Mechanical, Industrial, Biomedical, Bioprocess Engineering or related to Life Science field or equivalent experience or skillset.
• CQE, ASQ, APICS, Six Sigma Green Belt/Black Belt preferred.