Quality Assurance Manager

3 weeks ago


Westwood, Massachusetts, United States Michael Page Full time
Senior Quality Manager Role

We are seeking an experienced Senior Quality Manager to join our team in Westwood, MA. In this leadership role, you will be responsible for managing quality assurance and control teams, ensuring compliance with regulatory requirements and industry standards.

About the Job
  • Manage QA and QC teams to support organizational functions and ensure product quality.
  • Lead Quality Management System (QMS) activities, including CAPA, NCMR, audits, and complaints.
  • Coordinate global QMS processes to ensure consistency across multiple sites.

In this role, you will have the opportunity to work on new product development, ensuring regulatory compliance and quality throughout the process. You will also drive a culture of quality and continuous improvement across the organization.

About You
  • Expert in ISO 13485, ISO 9001, FDA QSR, IVDR, and safety standards.
  • 10+ years of quality systems experience in medical devices and in vitro diagnostics (IVD).
  • 5+ years of leadership in team management and performance development.

This is a leadership role that requires strong communication and organizational skills. As the successful candidate, you will have a proven track record of managing ISO/MDSAP audits and regulatory inspections.

What We Offer
  • Leadership Role: Directly manage and lead Quality Assurance (QA) and Quality Control (QC) teams.
  • Strategic Impact: Lead and enhance the Quality Management System (QMS), including CAPA, audits, and compliance processes.
  • Global Exposure: Coordinate and align QMS activities with global teams.
  • Compensation Package: $120,000 - $150,000 per year, depending on experience.

MPI is committed to creating a diverse and inclusive workplace. We welcome applications from qualified candidates who share our values and are passionate about delivering exceptional results.



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