Supplier Quality Engineer Lead
About the role
The Supplier Quality Engineer Lead is responsible for strategic leadership and execution of the Global Supplier Quality Management Program. This role provides functional leadership across supplier quality activities, ensures regulatory and QMS compliance, and drives continuous improvement across critical and strategic suppliers.
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.
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.
Experience: 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.
Work Environment
Manufacturing, clean room, warehouse, and office environments. May require extended periods of sitting, standing, and movement in production and supplier facilities.
Benefits
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.