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 (on-site)

Scope:

The Senior Supplier Quality Engineer is responsible for leading and driving all aspects of the Global Supplier Quality Management Program. This role ensures supplier compliance with regulatory requirements, corporate quality standards, and business expectations, while proactively improving supplier performance, risk management, and product quality.

This position serves as a subject matter expert (SME) for supplier quality and works independently with minimal supervision while mentoring junior engineers and influencing cross‑functional teams.

The Senior Supplier Quality Engineer leads supplier qualification, monitoring, auditing, development, and corrective action activities for critical and strategic suppliers. This role has ownership of complex supplier quality issues, including Risk 1 suppliers, outsourced processes, and high‑impact supplier changes, and plays a key role in management review, audit readiness, and continuous improvement initiatives.

Supplier Quality Leadership

• 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.
• Provide guidance and mentorship to 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.
• Ensure audit findings, risk assessments, and follow‑up actions are effectively managed and closed.
• 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, Pareto analysis, and risk review tools.
• Present supplier performance metrics and risk assessments to Management Review and senior leadership.

Supplier Audits & Compliance

Supplier Performance & Risk Management

Corrective Actions & Change Management

• 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 when required.
• Evaluate and support Supplier Change Notifications (SCNs) and change impact assessments.

Supplier Development & Continuous Improvement

• Lead supplier development initiatives to improve quality, delivery, compliance, and business continuity.
• Support new product introduction (NPI), supplier transfers, localization projects, and business continuity initiatives.
• Support and influence 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.

Quality Systems & Documentation

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 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.

Experience:

• 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.

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.

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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.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

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 pay for this role is between $100,000.00 - $125,000.00 annually. The actual base pay includes 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.