Quality Assurance Director

Leading the implementation and continuous improvement of a compliant Quality Management System, the full-time remote Quality Assurance Director will manage regulatory compliance, audit readiness, and quality operations while fostering a culture of quality and accountability within the team. Key responsibilities Lead the development and maintenance of the Quality Management System (QMS) ensuring compliance with FDA and ISO standards Serve as the primary quality representative during FDA inspections and audits, overseeing all audit preparation and follow-up activities Direct investigations of nonconforming products and quality system issues, implementing corrective actions and continuous improvement initiatives Required qualifications Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field; master's degree preferred 8-10 years of progressive quality experience in the medical device industry, with 3-5 years in a leadership role Strong knowledge of FDA Quality System requirements and ISO 13485, including experience with Class I and/or Class II medical devices Proven track record of leading FDA inspections and ISO certification audits, as well as improving Quality Management Systems Preferred certifications include ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)