Lead, Quality Engineering (Remote)

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. 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. Trumbull, CT or Livingston, NJ (on-site)

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.

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

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).

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.

Travel: This position may require 15‑30% domestic and/or international travel.

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.

Manufacturing, clean room, warehouse, and office environments.

May require extended periods of sitting, standing, and movement in production and supplier facilities.

Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Biomedical, Bioprocess Engineering or related to Life Science field or equivalent experience or skillset.

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, no phone calls or emails to any employee of CooperSurgical about this opening. 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.