What are the responsibilities and job description for the Senior Manager Quality Assurance, Medical Device (Sustaining) position at BioSpace?
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 States
Work model: Monday-Friday, 8am-4:30pm
Discover Your Role
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 combination product
Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities
Combination Product Support:Act as Management Representative for the combination products QMS; own policies and procedures
Support regulatory inspections and partner audits for combination products
Keep the QMS current and inspection-ready via monitoring, gap assessments, and updates
This Role Requires
BS in Engineering and 8 years of experience; including combination product or medical device experience; or equivalent combination of education & experience
Previous supervisory/ people leadership experience
Knowledge of the combination device development and lifecycle process
#REGNQA
Does 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. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
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 States
Work model: Monday-Friday, 8am-4:30pm
Discover Your Role
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 combination product
Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities
Combination Product Support:Act as Management Representative for the combination products QMS; own policies and procedures
Support regulatory inspections and partner audits for combination products
Keep the QMS current and inspection-ready via monitoring, gap assessments, and updates
This Role Requires
BS in Engineering and 8 years of experience; including combination product or medical device experience; or equivalent combination of education & experience
Previous supervisory/ people leadership experience
Knowledge of the combination device development and lifecycle process
#REGNQA
Does 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. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)