Supplier Quality Engineer Lead
Job in
Trumbull, Fairfield County, Connecticut, 06611, USA
Listed on 2026-07-10
Listing for:
The Cooper Companies
Full Time
position Listed on 2026-07-10
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Cooper Surgical 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 Cooper Companies, 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
Work location:
Trumbull, CT or Livingston, NJ (on-site)
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…
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