Manager, Medical Device Quality (Sustaining Engineering)

We are currently looking to fill a Manager, Medical Device Quality Assurance position. This position will provide QA oversight of the Medical Device function including combination products, including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed internally and in collaboration with partners and CMO’s. Supports the work using quality risk management principles and their application to medical device development and commercialization. The scope will involve collaboration with internal and external partners, primarily post-transfer and commercial activities.

In this role, a typical day might include the following:

• Advise and participate in Design Reviews associated with combination products and/ or medical devices
• Responsible for the management and development of quality engineering team members
• Interact with partners and contract organizations to ensure accurate completion of project achievements, including impact of changes and post-commercialization activities
• Maintain the quality risk management file for commercial combination products within Regeneron including data driven risk assessments (risk identification, analysis and ranking)
• Represent Regeneron’s medical device QMS during regulatory inspections and partner audits
• Provide QA oversight and support to combination products in the sustainability phase of commercialization
• Provide technical support to quality engineers and regulatory team during maintenance of the combination product
• Provide leadership to team, including sustaining engineering support.
• Support sustaining engineering programs through risk evaluation, design change, and maintain the design history file

This role may be for you if you:

• Have proven experience in global applications of Quality Assurance and Quality Risk Management in the medical device/combination products field
• Possess excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences
• Thrive in a quality focused environment

To be considered for this role you must hold a Bachelors degree in Mechanical or Biomedical engineering or equivalent with the following amount of related experience in the pharmaceutical/medical device/biotechnology industry:

• Sr Manager – 8+ years
• Associate Manager – 6+ years
• Manager – 7+ years

Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you?to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. $86,900.00 - $194,200.00