Senior Design Quality Engineer

About the role

CooperSurgical is seeking a Senior Design Quality Engineer to lead quality activities across product development for its women’s health medical devices. The role combines hands‑on design verification, risk management and supplier oversight to ensure compliance with regulatory standards.

Key responsibilities

• Represent the Quality function on product and process development teams, guiding design control, verification, validation and risk assessments.
• Manage supplier tooling and PPAP activities, define inspection plans and ensure purchased components meet specifications.
• Lead investigations of complex product issues, drive CAPA implementation and disposition of non‑conforming materials.
• Participate in design reviews, prototype testing and creation of design input requirements.
• Develop master test plans, evaluate test protocols and ensure compliance with FDA and international regulations.
• Conduct FMEA and other risk‑management activities throughout the development lifecycle.
• Identify and lead continuous‑improvement initiatives across cross‑functional teams.

Required profile

• 5+ years of Quality Engineering experience in the medical device industry.
• Bachelor’s degree in engineering or a related scientific field; ASQ Certified Quality Engineer preferred.
• Experience leading cross‑functional teams and managing supplier relationships.
• Willingness to travel up to 5 % domestically or internationally.

Required skills

• Proficiency in Microsoft Excel, Word and PowerPoint.
• Knowledge of ISO 13485 and ISO 14971 standards.
• FMEA and other risk‑management tool expertise.
• Statistical analysis and data‑driven decision making.
• ASQ Certified Quality Engineer certification (preferred).