Senior Supplier Quality Engineer- External Manufacturing

CooperCompanies•Trumbull, CT

14h•$100,000 - $125,000•Onsite

About The Position

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. The Senior Supplier Quality Engineer (External Manufacturing) is responsible for providing quality oversight of external manufacturing and supplier quality. The Senior Supplier Quality Engineer (External Manufacturing) is responsible for managing the external and contract manufacturing, ensuring that products manufactured by third‑party suppliers meet Cooper Surgical’s quality, regulatory, and performance standards. This role acts as the primary technical interface between CooperSurgical and its external suppliers, driving quality systems, leading issue resolution, and supporting continuous improvement across the supply base. Plays a critical role in supplier qualification, ongoing performance management, process validation, and ensuring compliance with internal standards and external regulations.

Requirements

5+ years in supplier quality, external manufacturing, or process engineering or relevant experience.
7+ years in a regulated quality environment (medical device, pharma, life sciences).
Bachelor’s degree in engineering (Mechanical, Industrial, Manufacturing, Chemical, or equivalent) or equivalent experience or skillset.
Strong understanding of manufacturing processes (injection molding, machining, assembly, packaging, electronics, finished good manufacturing etc., depending on industry).
Proficiency with quality tools: APQP, PPAP, FMEA, SPC, MSA, AQL.
Ability to analyze data and interpret statistical trends.
Experience with global manufacturing and supplier management.
Familiarity with international regulatory requirements and market trends
Strong communication and negotiation with external suppliers.
Ability to influence without authority.
Cross‑functional leadership and project management skills.

Nice To Haves

Experience working with global suppliers and contract manufacturers preferred.
Certifications (Lead Auditor, ASQ CQE, Six Sigma Green/Black Belt) preferred.

Responsibilities

Oversee the management of external manufacturing suppliers for development and execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers.
Lead routine operational quality reviews with external manufacturing partners to ensure ongoing compliance with quality system requirements, product specifications, and key operational metrics.
Provide day-to-day quality oversight of contract manufacturing operations, including batch record review, production monitoring, nonconformance management, and escalation of quality issues.
Review and trend quality data from external manufacturing sites, including deviations, scrap, yield, complaints, rework, and CAPA effectiveness, identifying opportunities for risk reduction and continuous improvement.
Approve suppliers based on risk, performance history, and alignment with business needs.
Lead PPAP/FAI reviews and ensure successful qualification of new products or components.
Proactively identify, develop, and lead the investigation and resolution of supplier-related challenges, and implement appropriate Quality Engineering methodologies, in support of supplier-related changes, risk management, to improve supplier reliability, minimize risks, and ensure sustainable material supply.
Provide SQ support to purchasing control audits of our external manufacturing sites. Maintain supplier quality documentation, audit reports, and qualification packages.
Participate in Material Review Board (MRB) activities and support containment, rework and disposition decisions and defect prevention activities for nonconforming products and materials manufactured by external partners.
Review and approve process validation protocols (IQ/OQ/PQ).
Ensure adherence to control plans, PFMEA, and SOPs.
Support engineering changes, product transfers, tooling validation, and ramp‑ups. Ensure change control processes are followed for materials, processes, and equipment.
Ensure all external manufacturing activities comply with industry regulations and organizational policies.
Support quality management reviews, audits, timely investigation of deviations, CAPAs and product disposition.
Support NPI products to align with R&D timelines, quality standards, and operational limitations.
Perform on-site quality oversight visits at contract manufacturing facilities to verify compliance, process adherence, operational controls, and execution of corrective actions
Monitor manufacturing performance using Operational Excellence (OPEX) metrics as appropriate; provide regular updates to supply chain leadership
Ensure timely communication with third-party manufacturers regarding product forecasts, manufacturing, and delivery schedules.
Ensure adherence to terms in the Supply Agreement and Quality Agreement.
Provide regular updates and reports to the supply chain leadership.
Monitor and report supplier quality performance (PPM, defect trends, NCRs, OEE, delivery, Complaint rates, SCAR closure effectiveness).
Lead monthly/quarterly business reviews with key suppliers.
Develop and execute supplier improvement plans.
Manage scorecards and continuous improvement expectations.
Work as a liaison between the suppliers and Cooper Surgical team.