Director, Quality Assurance And Vigilance

479

North Andover, MA, United States
$185,000-$205,000; bonus plan with a target of 16%...
Hybrid
Design assurance
Risk management
Design controls
This role leads the local Quality organization, owns and maintains the Design Center’s QMS, and serves as the Site Quality Management Representative

Job Summary

  • This role leads the local Quality organization, owns and maintains the Design Center’s QMS, and serves as the Site Quality Management Representative.
  • The Director ensures that all products developed at the site meet applicable regulatory, compliance, safety, and performance requirements throughout their lifecycle.
  • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

Matching Summary

This role leads the local Quality organization, owns and maintains the Design Center’s QMS, and serves as the Site Quality Management Representative.

Salary

$185,000-$205,000; Bonus plan with a target of 16% of base salary; Comprehensive benefits package including 401(k) with company contributions, paid time off, and health coverage

Skills & Requirements

Must-have

  • Design Assurance
  • Risk Management
  • Design Controls
  • ISO 13485
  • FDA QSR/QMSR
  • ISO 14971
  • Design Transfer

Nice-to-have

  • Infusion Pumps, Sets and Systems experience
  • ASQ or RAPS certification
  • Proactive quality culture
  • Continuous improvement mindset

Key Requirements

  • Over 10 years of experience
  • 5 years of management experience
  • Experience with FDA inspections and Notified Body audits
  • US work authorization required

Work Rights

Authorized to work for ANY employer in the United States

Tailored Resume

Cover Letter