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

Insulet Corporation

Acton, Ma, US
Base: $210,200.00 - $315,275.00; bonus/equity: may...
Hybrid
Quality system compliance
Iso 13485
21 cfr 820
The Sr. Director of Quality Operations will manage Regional and site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable regional and/or country-specific regulatory requirements

Job Summary

  • The Sr. Director of Quality Operations will manage Regional and site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable regional and/or country-specific regulatory requirements.
  • Establishes, maintains and promotes a culture of compliance and a keen focus on quality and customer requirements throughout the site organization.
  • We offer a comprehensive benefits package, including: Medical, dental, and vision insurance; 401(k) with company match; Paid time off (PTO); And additional employee wellness programs.

Matching Summary

The Sr. Director of Quality Operations will manage Regional and site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable regional and/or country-specific regulatory requirements.

Salary

Base: $210,200.00 - $315,275.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Quality System compliance
  • ISO 13485
  • 21 CFR 820
  • MDR compliance
  • Corrective and Preventive Action system
  • Document Control process

Nice-to-have

  • culture of compliance
  • customer requirements focus
  • continuous improvement

Key Requirements

  • Bachelor's degree in science or engineering
  • 15+ years in Medical Device Quality Operations
  • 10+ years at Quality Manager level
  • MS Word, Excel, Access, Auto Cad skills

Work Rights

Not specified

Tailored Resume

Cover Letter