Director, Quality Assurance And Vigilance

479

North Andover, MA, US
Base: $185,000-$205,000; bonus: target 16% of base...
Hybrid
10+ years quality experience in medical devices
5+ years managing individuals and teams
Expert knowledge of fda qsr/qmsr and iso 13485
The Director serves as the senior quality leader responsible for owning the Design Center's Quality Management System and ensuring all products meet regulatory and safety requirements

Job Summary

  • The Director serves as the senior quality leader responsible for owning the Design Center's Quality Management System and ensuring all products meet regulatory and safety requirements.
  • This role requires leading the site organization through FDA inspections, Notified Body audits, and driving a culture of continuous improvement and right-first-time execution.
  • The position offers a competitive salary range of $185,000-$205,000 with a 16% bonus target and comprehensive benefits including health coverage and 401(k) contributions.

Matching Summary

The Director serves as the senior quality leader responsible for owning the Design Center's Quality Management System and ensuring all products meet regulatory and safety requirements.

Salary

Base: $185,000-$205,000; Bonus: Target 16% of base salary; Benefits: 401(k), medical, dental, vision, paid time off

Skills & Requirements

Must-have

  • 10+ years quality experience in medical devices
  • 5+ years managing individuals and teams
  • Expert knowledge of FDA QSR/QMSR and ISO 13485
  • Proven track record leading FDA inspections and audits
  • Deep expertise in Design Controls and Risk Management

Nice-to-have

  • Experience with infusion pumps, sets, and systems
  • ASQ or RAPS certification preferred
  • Strategic thinking and change agent capabilities
  • Strong cross-functional collaboration skills
  • Knowledge of EU MDR and MDSAP requirements

Key Requirements

  • Over 10 years of previous experience
  • 5 years of experience managing individuals
  • In-depth knowledge of 21 CFR Parts 11 and 820
  • Demonstrated experience with FDA inspections
  • Authorized to work for any employer in the US

Work Rights

Must be authorized to work for any employer in the United States

Tailored Resume

Cover Letter