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Skills Alliance

Director of Quality Assurance

Skills Alliance, MA, United States

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Recruitment Consultant | Medical Devices QA United States

Director of Quality Assurance

Location: Massachusetts, United States

About:

A fast-growing medical device company at the forefront of cardiology innovation are looking for a Director of Quality Assurance. Their mission is to improve patient outcomes through high-quality, compliant, and reliable devices that meet the most rigorous international standards.

The Opportunity:

The company is looking for a Director of Quality Assurance to lead the QA function and shape the future of their quality systems. This role offers you the platform to build on your proven expertise in ISO 13485, supplier quality, and regulatory compliance , while stepping into a more strategic leadership position.

Responsibilities:

  • Lead and manage internal and external audits , driving successful ISO 13485 and MDSAP compliance.
  • Oversee supplier quality and vendor assessments , applying your experience to strengthen our supply chain.
  • Own and continuously improve the Quality Management System (QMS) , ensuring regulatory compliance and operational excellence.
  • Collaborate closely with R&D, manufacturing, and regulatory affairs to embed quality at every stage of product development.
  • Coach and mentor QA professionals, building a high-performing team and culture of quality.
  • Serve as the primary QA voice with senior leadership and external regulators , providing insights to shape company strategy.

Requirements:

  • Minimum 10 years of progressive experience in Quality Assurance , ideally in the medical devices sector.
  • Strong knowledge and hands-on expertise with ISO 13485, ISO 14971, FDA, and MDR frameworks .
  • Demonstrated success leading audits, supplier quality programs, and QMS improvements .
  • Excellent leadership, communication, and stakeholder management skills.
  • A strategic mindset with the ability to influence cross-functional teams and senior decision-makers

For further information please contact me:

Seniority level

  • Seniority level

    Director

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Quality Assurance

  • Industries

    Medical Equipment Manufacturing

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