Senior Supplier Quality Engineer

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. Our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We provide over 600 clinically relevant medical devices to healthcare providers, including testing, treatment, assisted reproductive technology, and genomic testing solutions.

About the role

The Senior Supplier Quality Engineer leads and drives all aspects of the Global Supplier Quality Management Program, ensuring supplier compliance with regulatory requirements, corporate quality standards, and business expectations. This role serves as a subject matter expert for supplier quality, mentors junior engineers, and influences cross-functional teams while working independently with minimal supervision.

Responsibilities

• Lead end-to-end supplier quality activities for assigned suppliers, including onboarding, qualification, monitoring, re-evaluation, and disqualification.
• Act as Supplier Quality SME for critical suppliers, outsourced processes, and complex supply chain issues; mentor Supplier Quality Engineers and cross-functional stakeholders.
• Plan, perform, and lead supplier audits (on-site, remote, desktop) in accordance with internal procedures and regulatory expectations; manage audit findings, risk assessments, and follow-up actions.
• Serve as a key contributor during regulatory inspections and notified body audits, supporting back-room activities and supplier-related inquiries.
• Lead supplier risk classification, risk assessments, and mitigation planning; drive supplier performance monitoring using metrics, trend analysis, and risk review tools.
• Present supplier performance metrics and risk assessments to Management Review and senior leadership.
• Own and drive Supplier Corrective Action Requests (SCARs), ensuring robust root cause analysis, effective corrective actions, and sustained improvement.
• Lead supplier-related Nonconforming Material Reports (NCMRs) and support escalation management.
• Evaluate and support Supplier Change Notifications (SCNs) and change impact assessments.
• Lead supplier development initiatives to improve quality, delivery, compliance, and business continuity; support new product introduction (NPI), supplier transfers, and localization projects.
• Support IQ, OQ, PQ, PPAP, validation, and qualification activities from a supplier quality perspective.
• Develop, maintain, and improve Supplier Quality Agreements and supplier management SOPs, forms, and workflows.
• Ensure supplier records and documentation are complete, accurate, and compliant with QMS and regulatory requirements.
• Collaborate with Procurement, Engineering, Operations, and Regulatory teams to ensure supplier alignment across the product lifecycle.

Requirements

• 7+ years experience in a regulated quality environment (medical device, pharma, life sciences).
• 5+ years direct experience in Supplier Quality Management.
• Demonstrated experience leading supplier audits, complex SCARs, supplier development, and compliance initiatives.
• Expert knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.
• Strong experience with supplier risk management, audits, SCAR/CAPA, and performance monitoring.
• Proven ability to lead cross-functional teams and influence without authority.
• Advanced problem-solving skills using quality tools (e.g., root cause analysis, FMEA, statistical methods).
• Strong written and verbal communication skills, including interaction with senior leadership and external suppliers.
• Proficient in MS Office, Minitab, and experience with ERP and eQMS systems.

Qualifications

• Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Biomedical, Bioprocess Engineering or related Life Science field or equivalent experience.
• CQE, ASQ, APICS, Six Sigma Green Belt / Black Belt preferred.

Work Environment

• Manufacturing, clean room, warehouse, and office environments.
• May require extended periods of sitting, standing, and movement in production and supplier facilities.
• 15-30% domestic and/or international travel may be required.

Location

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

Benefits

• Competitive compensation package.
• Medical coverage.
• 401(k) retirement plan.
• Parental leave and fertility benefits.
• Paid time off for vacation, personal, sick, and holidays.
• Additional perks and benefits.

Pay

The starting base pay for this role is between $100,000.00 - $125,000.00 annually, with eligibility for other types of compensation and benefits.