Principal Supplier Quality Engineer

CooperSurgical, Inc.; Trumbull (CT); On-site; USD 120,000 - 160,000; Full time

Job summary

CooperSurgical, Inc. is seeking a Principal Supplier Quality Engineer to provide strategic technical leadership for supplier quality systems, process validation, risk management, auditing, and supplier development across global networks.

The role drives quality excellence within the product lifecycle and partners with Engineering, Operations, Regulatory Affairs, R&D, Manufacturing, and business leadership to ensure supplier processes meet regulatory, customer, and business requirements.

Qualifications

• High standards for supplier quality systems and processes.
• Deep knowledge of regulatory requirements and quality controls.
• Experience with risk management and supplier audits.

Responsibilities

• Lead supplier quality strategy for enterprise-wide initiatives.
• Oversee process validation, auditing, and supplier development.
• Coordinate external manufacturing oversight and compliance decisions.
• Collaborate with Engineering, Operations, Regulatory Affairs, R&D, and Manufacturing.

Skills

Supplier quality

Quality systems

Regulatory compliance

Risk management

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 Principal Supplier Quality Engineer serves as the highest-level technical authority within Supplier Quality Engineering and provides enterprise-wide leadership for supplier quality strategy, technical risk management, product realization, and supplier compliance activities. This role is responsible for establishing technical standards, leading complex quality initiatives, and providing expert guidance on supplier-related product, process, and compliance decisions.

The Principal Supplier Quality Engineer drives quality excellence across the product lifecycle and partners with Engineering, Operations, Procurement, Regulatory Affairs, R&D, Manufacturing, and business leadership to ensure supplier processes and product quality meet regulatory, customer, and business requirements. The role operates with significant autonomy and serves as a recognized subject matter expert for critical supplier quality and engineering challenges.

Job Summary:

The Principal Supplier Quality Engineer provides strategic technical leadership for supplier quality systems, process validation, risk management, auditing, supplier development, product realization and external manufacturing operational oversight activities. This role leads to the resolution of highly complex quality and engineering issues impacting product safety, efficacy, reliability, compliance, and supply continuity.

The position serves as the organization's technical expert for supplier-related quality engineering matters, including design transfer, process validation, manufacturing controls, risk management, supplier change management, and regulatory inspection support. The Principal Supplier Quality Engineer influences business strategy through technical expertise and drives continuous improvement across global supplier networks.

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)