Lead Quality Management Specialist

1 day ago


Westwood, Massachusetts, United States Michael Page Full time

The Senior Quality Manager position at Michael Page is a key role in ensuring the Quality Management System (QMS) for medical device products aligns with regulatory standards. The ideal candidate will oversee QA/QC teams, lead audits and inspections, and support cross-functional teams in new product development while promoting continuous quality improvement.

Our client, a renowned company in the medical and biotechnology industries, fosters an innovative work environment that encourages collaboration and growth. Employees appreciate its focus on continuous improvement, regular training, and mentorship opportunities. The company prioritizes customer-centric solutions, demonstrating strong leadership in its field.

The Senior Quality Manager will be responsible for:

  • Managing QA/QC teams to support operational functions
  • Oversight of the QMS, including CAPA, NCMR, and audits
  • Ensuring compliance with ISO 13485 and FDA QSR regulations
  • Leading internal and external audits and regulatory inspections
  • Supporting cross-functional teams in new product development
  • Reviewing and approving product changes, adhering to design control procedures
  • Fostering a culture of continuous improvement

Competitive compensation as well as a bonus package awaits the successful candidate, along with hybrid work arrangements, state-of-the-art technology, and comprehensive benefits.



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