Design Quality Engineer

Position: Staff Design Quality Engineer
About Cooper Surgical

Cooper Surgical 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 business unit of Cooper Companies (Nasdaq: COO), we're driven by a unified purpose of helping people 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

Work location:

Trumbull, CT or Livingston, NJ (on-site)

Scope:

The Staff Design Quality Engineer is an experienced technical individual contributor responsible for ensuring the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle. This position provides technical expertise in implementing and maintaining quality management system requirements, leading design control and risk management activities for product development projects, and supporting the execution of quality and business objectives established by leadership.

The Staff DQE collaborates with internal and external cross-functional teams to deliver high-quality medical device solutions that meet regulatory, customer, and business requirements.

This position serves as a key quality representative on product development and sustaining engineering projects, providing guidance on quality engineering principles, design controls, risk management, verification and validation activities, and supplier quality processes. The Staff DQE influences project-level quality decisions, drives compliance to applicable standards and regulations, and supports continuous improvement initiatives within the organization.

Job Summary:

The Staff Design Quality Engineer provides technical leadership and quality engineering support to ensure the successful development, transfer, and ongoing support of Cooper products. This individual applies knowledge of design controls, risk management, verification and validation principles, quality engineering techniques, and supplier quality processes, including supplier collaboration and PPAP execution, to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations.

The Staff Design Quality Engineer provides guidance on scientific and technical data related to product design, manufacturing processes, and product testing to support quality and compliance objectives. This position partners cross-functionally with R&D, Operations, Regulatory, Supplier Quality and Clinical teams. The Staff DQE provides guidance and knowledge sharing to peers and less experienced engineers, contributes to problem-solving activities and continuous improvement efforts, and supports the successful execution of product development and sustaining engineering programs.

* Design Quality Leadership

* Represent the Quality function on product/process development teams.

* Mentor other discipline as needed in the Quality Engineering methodology.

* Ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, design reviews, and design changes. May serve as independent reviewer during design reviews, or conduct DHF audits, as required.

* Owner/Approver of one or more processes within the scope of Design Quality.

* Supplier Engagement

* Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper's specifications.

* Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.

* Lead and actively support supplier quality activities, including close collaboration with external suppliers to ensure components, assemblies, and processes meet design specifications, quality requirements, and applicable regulatory standards.

* Demonstrate strong working knowledge and hands‑on experience with Production Part Approval Process (PPAP) execution, including review and approval of supplier deliverables such as PFMEAs, control plans, process flow diagrams, capability studies, and dimensional layouts

* Ensure that supplier‑provided PPAP and qualification documentation is complete, accurate, and aligned with design intent, risk management outputs, and validation requirements.

* Partner with Supply Chain, Engineering, Manufacturing, and Regulatory teams to ensure suppliers are properly qualified and able to consistently deliver production‑representative…