Senior Supplier Quality Engineer- External Manufacturing
CooperCompaniesAbout 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 (hybrid) Scope: The Senior Supplier Quality Engineer (External Manufacturing) is responsible for providing quality oversight of external manufacturing and supplier quality. Job Summary: 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. 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) Knowledge, Skills and Abilities: 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. Experience: 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). Experience working with global suppliers and contract manufacturers preferred. 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 engineering (Mechanical, Industrial, Manufacturing, Chemical, or equivalent) or equivalent experience or skillset. Certifications (Lead Auditor, ASQ CQE, Six Sigma Green/Black…