Quality Engineer Principal

Conduct comprehensive quality assurance reviews for fertility and women's healthcare medical devices, ensuring compliance with regulatory standards and internal protocols. Perform root cause analysis on device failures and lead cross-functional teams in developing corrective and preventive actions. Manage the full lifecycle of quality documentation, including design controls, validation studies, and risk management files for over 600 clinically relevant products. Collaborate with engineering and clinical teams to verify that assisted reproductive technology and genomic testing solutions meet safety and efficacy requirements. This role supports CooperSurgical's mission to enable patients to experience life's beautiful moments through reliable healthcare devices.