Senior Quality Director for Medical Devices

6 days ago


Westwood, Massachusetts, United States Michael Page Full time

The company Michael Page is seeking a Senior Quality Director for Medical Devices to lead and manage the Quality Assurance and Control teams at their Westwood, MA location.

Job Overview:

The Senior Quality Director will oversee the implementation and continuous improvement of the site's Quality Management System (QMS), ensuring compliance with regulatory requirements and driving process improvements.

Key Responsibilities:

  • Manage Quality Assurance (QA) and Quality Control (QC) teams to support organizational functions
  • Lead and maintain the site's QMS, including CAPA, NCMR, complaints, audits, and management reviews
  • Coordinate QMS activities across global sites to ensure alignment and compliance
  • Collaborate cross-functionally on new product development, ensuring robust requirements, specifications, and test protocols
  • Review and support product and manufacturing process changes, focusing on risk management and design control compliance
  • Act as the organization's QMS expert, staying updated on evolving industry regulations and standards
  • Drive a culture of quality and continuous improvement throughout the organization
  • Oversee validation and verification processes to ensure compliance with internal and external requirements
  • Provide strategic input on quality initiatives to enhance operational excellence and product reliability

Requirements:

  • In-depth knowledge of ISO 13485, ISO 9001, FDA QSR, IVDR, and relevant product safety standards
  • 10+ years of quality systems experience, with a focus on medical devices and in vitro diagnostics (IVD)
  • 5+ years of direct management experience, including team development and performance management ideally in a Quality Manager or Senior Quality Manager title
  • Expertise in managing ISO/MDSAP audits, customer audits, and regulatory inspections
  • Proficiency with electronic QMS software and business intelligence tools
  • Strong organizational, verbal, and written communication skills to lead and collaborate effectively

Estimated Salary: $130,000 - $160,000 per year, depending on experience. Benefits include three weeks of vacation to start, increasing with tenure (up to five weeks), sixty-four hours of sick time and eleven holidays annually, a 401(k) plan with 40% company match (up to IRS limits), and health insurance with no deductible.



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