Quality Assurance Director

Job Summary

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)