Highly Regarded Quality Leadership Position

6 days ago


Westwood, Massachusetts, United States Michael Page Full time
About the Role

We are seeking a Senior Quality Manager to oversee our Quality Management System, ensuring compliance with regulatory standards such as ISO 13485 and FDA QSR.

The ideal candidate will possess a strong background in quality systems management for medical devices, with at least 10 years of experience in quality management, particularly with in vitro diagnostics.

Key Responsibilities
  • Manage QA/QC teams to support all operational functions.
  • Oversee the site's Quality Management System (QMS), including CAPA, NCMR, and audits.
  • Ensure compliance with regulatory standards such as ISO 13485 and FDA QSR.
  • Lead internal and external audits and regulatory inspections.
  • Support cross-functional teams in new product development to meet quality requirements.
  • Review and approve product changes, ensuring compliance with design control procedures.
  • Drive continuous improvement and foster a culture of quality.
About Our Company

Our client is a highly regarded company in the medical and biotechnology industries, known for its innovative contributions and commitment to customer-centric solutions.

As a valued member of our team, you will have access to state-of-the-art technology, a hybrid work schedule, and excellent professional development opportunities.

What We Offer
  • Competitive compensation package.
  • Hybrid work schedule.
  • State-of-the-art technology and facilities.
  • 401(k) Retirement Plan with employer matching contributions.
  • Health Insurance, including medical, dental, and vision coverage.
  • Paid Time Off (PTO) and generous vacation, sick leave, and holiday pay.
  • Life and Disability Insurance.
  • Professional Development Opportunities.
  • Wellness Programs.


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