Associate Manager, Medical Device Quality (Sustaining Engineering)

Manager, Medical Device Quality Assurance

We are currently looking to fill a Manager, Medical Device Quality Assurance position on our Medical Device Sustaining Engineering QA team. 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 :

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

This role may be for you if you :

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 :

Level is determined based on qualifications relevant to the role.