Sr. Manager, Medical Device Quality Assurance

Job description

Build our future together: Regeneron is currently seeking a Senior Manager, Medical Device Quality Assurance (QA) to join our Medical Device QA team. This expanded leadership role will provide QA oversight across two critical functions: Combination Products Sustaining Engineering and Compliance. The position will lead a team engineer and quality specialists. When & where: - Monday-Friday, 8am-4:30pm - Location: East Greenbush, New York, United States What you'll do: - Manage, mentor, and develop quality engineering and compliance teams - Standardize, streamline, and improve processes across sustaining and compliance - Implement digital, data-driven tools for accurate, consistent, and timely reporting - Lead teams through complex, ambiguous challenges in a pharmaceutical/medical device environment Sustaining Engineering Support: - Support sustaining engineering programs through risk assessment, design change management, and maintenance of the Design History File and Risk Management File - Advice and actively participate in Design Reviews associated with combination products - Provide QA and technical support to quality engineers and project teams during ongoing maintenance of the co...