Global Supplier Quality Lead

Regulatory Jobs; Trumbull (CT); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical in the United States seeks a Supplier Quality Engineer Lead to govern supplier qualification, compliance, audits, development, and escalation for high‑risk and strategic suppliers. You will lead global supplier quality governance, partner with Procurement, Operations, Engineering, Regulatory, and business leaders, and mentor a team of SQEs.

The role emphasizes regulatory interactions, audit readiness, and continuous improvement, with 15–30% travel and a hybrid work setup in

Qualifications

• Expert knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.
• Strong leadership in supplier quality governance, audits, CAPA/SCAR, and risk management.
• Executive-level communication with internal leadership and external suppliers.

Responsibilities

• Define and lead supplier quality strategy aligned with regulatory requirements.
• Provide mentoring to Supplier Quality Engineers.
• Escalation point for supplier quality issues, Risk 1 suppliers, and supply chain disruptions.
• Influence senior leadership decisions related to supplier risk, sourcing strategy, and business continuity.
• Lead planning and execution of global supplier audits (onsite, remote, desktop).
• Close audit findings and compliance gaps.
• Act as primary Quality representative for supplier-related regulatory inspections, and health authority inquiries.
• Establish and oversee supplier risk classification, risk assessment, and mitigation frameworks.
• Review, trend, and present supplier performance metrics to Management Review.
• Provide oversight for SCARs, NCMRs, SCNs and change management.
• Lead supplier development initiatives focused on quality, delivery, resiliency.
• Support NPI, supplier transfers, localization, dual-sourcing.
• Provide quality leadership for supplier-facing validation activities (IQ/OQ/PQ, PPAP).
• Develop and maintain governance of Supplier Quality Agreements, SOPs, workflows, and metrics.
• Ensure supplier documentation remains compliant with QMS and regulatory expectations.
• Drive cross-functional alignment across the supplier lifecycle.

Skills

FDA QSR 21 CFR 820

ISO 13485

EU MDR

ISO 14971

Supplier Quality Leadership

Executive communication

Education

Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Biomedical, Bioprocess Engineering or Life Science

CQE / ASQ / APICS / Six Sigma Green Belt/Black Belt preferred

Tools

MS Office

Minitab

ERP

eQMS

Job description

CooperSurgical in the United States seeks a Supplier Quality Engineer Lead to govern supplier qualification, compliance, audits, development, and escalation for high‑risk and strategic suppliers. You will lead global supplier quality governance, partner with Procurement, Operations, Engineering, Regulatory, and business leaders, and mentor a team of SQEs.

The role emphasizes regulatory interactions, audit readiness, and continuous improvement, with 15–30% travel and a hybrid work setup in