Senior Design Quality Engineer

About the role

CooperSurgical seeks a Senior Design Quality Engineer to lead quality representation across product and process development, mentor teams, and ensure compliance with design control and regulatory requirements.

Key responsibilities

• Represent Quality on development teams, guide engineering on design verification, validation, risk management and design reviews.
• Manage supplier tooling qualification, PPAP processes and specification reviews.
• Lead investigations of complex product issues, drive CAPA implementation and disposition of non‑conforming materials.
• Participate in design reviews, prototype testing, and contribute to design input, documentation and manufacturing procedures.
• Develop master test plans, create and validate product and process test methods, and evaluate test reports for regulatory compliance.
• Identify and manage risk using FMEAs and other tools throughout development.
• Drive continuous improvement across cross‑functional teams and ensure adherence to ISO 13485 and ISO 14971.
• Maintain knowledge of FDA and international regulations, represent the company in audits and regulatory interactions.

Required profile

• 5+ years of Quality Engineering experience in the medical device industry.
• Strong project management, analytical and problem‑solving abilities.
• Excellent written and verbal communication in English.
• Experience leading cross‑functional teams and managing risk and CAPA processes.

Required skills

• Intermediate to advanced proficiency in Excel, Word and PowerPoint.
• Knowledge of ISO 13485 and ISO 14971 standards.
• Experience with FMEA, risk management tools, CAPA and PPAP processes.
• Statistical analysis and data‑driven decision making.