Quality Engineering Senior

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. 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.
Work location: Trumbull, CT or Livingston, NJ (on-site)
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.
Responsibilities
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.
Supplier Audits & Compliance

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.
Supplier Performance & Risk Management

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.
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.
Quality Systems & Documentation

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

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.