Associate Director, Quality Systems

Waters Corporation / BD

Sparks, MD, USA
Base: $154,400.00 - $254,800.00 usd annual; bonus/...
Fda qsr and iso 13485 compliance
Global quality management system design
Mdsap and mdr/ivdr regulatory standards
This role serves as a key quality leader responsible for designing and sustaining a robust Quality Management System across the Advanced Diagnostics division

Job Summary

  • This role serves as a key quality leader responsible for designing and sustaining a robust Quality Management System across the Advanced Diagnostics division.
  • The position requires acting as the Management Representative to ensure compliance with FDA, ISO 13485, MDSAP, and other global regulatory standards.
  • Candidates will lead external regulatory inspections, manage CAPA effectiveness, and develop the ADx Quality Systems team while reporting directly to the Sr. Director.

Matching Summary

This role serves as a key quality leader responsible for designing and sustaining a robust Quality Management System across the Advanced Diagnostics division.

Salary

Base: $154,400.00 - $254,800.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture

Skills & Requirements

Must-have

  • FDA QSR and ISO 13485 compliance
  • Global Quality Management System design
  • MDSAP and MDR/IVDR regulatory standards
  • CAPA and Change Control management
  • External audit and inspection leadership
  • Medical device quality systems experience

Nice-to-have

  • Professional certification CQA or CQE
  • Strategic partnership with senior leadership
  • Culture of continuous improvement
  • Digital e-QMS solution implementation
  • Cross-functional problem solving skills

Key Requirements

  • BS in scientific or engineering discipline
  • 8 years experience in Medical Device Quality
  • Thorough knowledge of ISO and FDA regulations
  • Experience managing exempt and non-exempt personnel

Work Rights

Not specified

Tailored Resume

Cover Letter