Senior Staff Design Quality Engineer

About the role

CooperSurgical is seeking a Senior Staff Design Quality Engineer to lead design quality activities for sterile medical devices. You will act as the Quality function representative on product development teams, ensuring compliance with design control requirements and driving continuous improvement.

Key responsibilities

• Represent Quality on product and process development teams and serve as the subject‑matter expert for sterile product design.
• Mentor colleagues in Quality Engineering methodology and act as an independent reviewer during design reviews and Design History File (DHF) audits.
• Ensure design verification, validation, risk management, specification development, and design change control are executed effectively.
• Participate in supplier selection, define quality characteristics, approve PPAP packages, and lead supplier qualification activities.
• Lead or support investigations of complex product problems, manage CAPA actions, and evaluate non‑conforming materials.
• Contribute to health risk assessments, health hazard evaluations, and recall processes.
• Provide input to design and manufacturing documentation, including material specifications, drawings, and inspection procedures.

Required profile

• Extensive experience in design quality for sterile medical devices.
• Proven ability to mentor and lead cross‑functional teams.
• Strong knowledge of design control regulations and quality system requirements.
• Experience managing supplier quality and PPAP processes.
• Demonstrated expertise in CAPA investigations and health risk assessments.

Required skills

• Design History File (DHF) auditing
• Production Part Approval Process (PPAP)
• Risk management and design verification/validation
• CAPA investigation and corrective action implementation
• Supplier qualification and quality characteristic definition