Senior Quality Assurance Analyst

Driving quality and compliance excellence, the full-time Senior Quality Assurance Analyst will manage CAPAs, support regulatory submissions, and ensure quality system execution while collaborating cross-functionally in a remote environment. Key responsibilities Lead and manage Corrective and Preventive Actions (CAPAs) and drive improvements to the Quality Management System (QMS) Support internal and external audits to ensure compliance with regulatory and internal requirements Collaborate with cross-functional teams to integrate quality and regulatory requirements into development processes Required qualifications Bachelor's degree in a scientific, engineering, or healthcare-related field, or equivalent industry experience 4+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry Demonstrated experience working within a certified Quality Management System (ISO 13485) Strong working knowledge of FDA 21 CFR Part 820 and ISO 14971 risk management principles Proven experience managing CAPA, audits, and supplier quality processes