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Director of Quality Assurance Medical Device - Massachusetts

Job Description

โ€‹Our client is a leading medical device innovator committed to improving patient outcomes. We're on the lookout for a strategic Director of Quality Assurance to lead our Massachusetts-based team in maintaining the highest standards of quality and regulatory compliance.๐Ÿฅ๐Ÿ”


  1. QMS Leadership: Develop and maintain a compliant Quality Management System (QMS) in line with ISO 13485 and FDA QSR.

  2. Regulatory Compliance: Ensure adherence to changing regulations and standards, keeping our products in compliance.

  3. Team Leadership: Lead and develop a high-performing quality assurance team, fostering a culture of continuous improvement.

  4. Metrics and Reporting: Establish and monitor key quality performance metrics, providing regular reports to senior management.

  5. Supplier Quality Management: Collaborate to ensure the quality of materials and components from suppliers.

  6. Product Lifecycle Management: Oversee quality throughout the product lifecycle, from development through post-market surveillance.


  1. Bachelor's degree in a relevant field; advanced degree preferred.

  2. Minimum 10 years of medical device quality assurance experience.

  3. Strong knowledge of ISO 13485, FDA QSR, and other relevant regulations.

  4. Proven leadership in managing regulatory inspections and audits.

  5. Excellent communication, interpersonal, and problem-solving skills.

  6. Certification in Quality Management (e.g., ASQ Certified Manager of Quality/Organizational Excellence) is a plus.

How to Apply:

Interested candidates should submit their resume and cover letter to ebun@meliolifescience with the subject line "Director of QA - Medical Device" by Wednesday, 6th December 2023. ๐Ÿ“ง๐Ÿ“…

Melio is an equal opportunity employer. ๐ŸŒ๐Ÿค

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