Senior Manager Quality Assurance, Medical Device (Sustaining)

About the role

Regeneron is 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.

Location & Schedule

East Greenbush, New York, United States. Monday–Friday, 8am–4:30pm.

Responsibilities

• 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
  • Advise 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

Requirements

• 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