Supplier Quality Engineer

Job Summary:

The Supplier Quality Engineer Lead governs supplier qualification, compliance, auditing, development, and escalation activities for high‑risk, high‑impact, and strategic suppliers. This role owns supplier quality strategy, serves as escalation point for complex supplier issues and regulatory interactions, and plays a key role in management review, audit readiness, and organizational quality maturity. The position provides leadership and mentoring to Supplier Quality Engineers and partners closely with Procurement, Operations, Engineering, Regulatory, and Business Leaders.

Essential Functions & Accountabilities:

Supplier Quality Leadership & Strategy

• 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.

Supplier Audits & Regulatory Compliance

• 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.

Supplier Performance & Risk Governance

• 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.

Corrective Action, Escalation & Change Management

• 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.

Supplier Development & Continuous Improvement

• 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).

Quality Systems & Governance

• 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

Knowledge, Skills and Abilities:

• 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.

Experience:

• Experience in Supplier/Vendor Quality Management.
• Multiple years experience in a regulated quality environment (medical device, pharma, life sciences).
• Proven leadership of high‑risk suppliers, regulatory interactions, and global supplier initiatives.

Work Environment:

• Manufacturing, clean room, warehouse, and office environments.
• May require extended periods of sitting, standing, and movement in production and supplier facilities.