Sr. Manager, Medical Device Quality Assurance
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 of engineers and quality specialists.When & where:Location: East Greenbush, New York, United StatesWork model: Monday-Friday, 8am-4:30pmDiscover your role:Manage, mentor, and develop quality engineering and compliance teamsStandardize, streamline, and improve processes across sustaining and complianceImplement digital, data-driven tools for accurate, consistent, and timely reportingLead teams through complex, ambiguous challenges in a pharmaceutical/medical device environmentSustaining Engineering Support:Support sustaining engineering programs through risk assessment, design change management, and maintenance of the Design History File and Risk Management FileAdvice and actively participate in Design Reviews associated with combination productsProvide QA and technical support to quality engineers and project teams during ongoing maintenance of the combination productInteract with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activitiesCombination Product Support:Act as Management Representative for the combination products QMS; own policies and proceduresSupport regulatory inspections and partner audits for combination productsKeep the QMS current and inspection-ready via monitoring, gap assessments, and updatesThis role requires:BS in Engineering and 8+ years of experience; including combination product or medical device experience; or equivalent combination of education & experiencePrevious supervisory/ people leadership experienceKnowledge of the combination device development and lifecycle process#REGNQADoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. ...