Associate Manager, Medical Device Quality (Sustaining Engineering)

Role Summary

Responsibilities

• 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

Qualifications

• Required: Bachelors degree in Mechanical or Biomedical engineering or equivalent with the following amount of related experience in the pharmaceutical/medical device/biotechnology industry: Associate Manager – 6+ years; Manager – 7+ years

Skills

• Thrive in a quality focused environment
• 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

Education

• Bachelors degree in Mechanical or Biomedical engineering or equivalent

Additional Requirements

• Level is determined based on qualifications relevant to the role