Supplier Quality Engineer 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

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Work location

Trumbull, CT or Livingston, NJ (hybrid)

Scope

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. The Lead operates with a high degree of autonomy, influences cross‑functional and senior leadership decisions, and sets direction for supplier quality governance, risk management, and performance improvement.

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.

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.

Travel

This position may require 15-30% domestic and/or international travel.

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

• 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.

Education

• 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.

Our 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.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base payfor this role is between$120,000.00 - $150,000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.