Sr Director, Global Quality Management Systems (hybrid - Acton, Ma)

Insmed Corporation

Acton, Massachusetts, United States
Base: $210,200.00 - $315,275.00; bonus/equity: eli...
Hybrid
15+ years medical device quality operations experience
10+ years at quality manager level
Expertise in iso 13485 and 21 cfr 820 regulations
The Sr. Director will manage regional and site-level Quality System compliance ensuring full alignment with US FDA and ISO 13485 requirements

Job Summary

  • The Sr. Director will manage regional and site-level Quality System compliance ensuring full alignment with US FDA and ISO 13485 requirements.
  • This role is responsible for establishing a robust employee training process and supporting sterilization controls and validation programs.
  • Candidates are eligible for a comprehensive benefits package including medical, dental, vision insurance, and a 401(k) with company match.

Matching Summary

The Sr. Director will manage regional and site-level Quality System compliance ensuring full alignment with US FDA and ISO 13485 requirements.

Salary

Base: $210,200.00 - $315,275.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, PTO

Skills & Requirements

Must-have

  • 15+ years Medical Device Quality Operations experience
  • 10+ years at Quality Manager level
  • Expertise in ISO 13485 and 21 CFR 820 regulations
  • Experience with MDR compliance requirements
  • Knowledge of Device Master Record release processes

Nice-to-have

  • Strong culture of compliance and continuous improvement
  • Statistically-based Quality Control process skills
  • Experience with new product launch expansion
  • Proficiency in MS Office and AutoCAD tools

Key Requirements

  • Bachelor's degree in science or engineering
  • 15+ years experience in Medical Device Quality Operations
  • 10+ years experience at Quality Manager level
  • Intermediate to advanced skill in MS Word, Excel, Access, AutoCAD

Work Rights

Not specified

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