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Skills Alliance

Director of Quality Assurance

Skills Alliance, Oklahoma City, Oklahoma, United States

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1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Skills Alliance 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: Hugh.Cross@SkillsAlliance.com Seniority level

Seniority level Director Employment type

Employment type Full-time Job function

Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Skills Alliance by 2x Sign in to set job alerts for “Director of Quality Assurance” roles.

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