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.
This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.
We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) with company match, paid time off, 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: Medical, dental, vision insurance, 401(k) with company match, PTO, wellness programs
Skills & Requirements
Must-have
Quality System compliance management
ISO 13485 and FDA regulations
Corrective and Preventive Action system
Quality Control processes
Document Control process
Hybrid working arrangements
Nice-to-have
Environmental Monitoring program support
Sterilization process validation
Employee training process
Environmental, Health, and Safety initiatives
Statistically-based quality control
Key Requirements
Bachelor's degree in science or engineering
15+ years Medical Device Quality Operations experience
10+ years Quality Manager level experience
Knowledge of ISO 13485, 21 CFR 820, MDR
Intermediate to advanced MS Word, Excel, Access skills