Summary: Seeking a Device Quality Assurance Specialist with experience in medical device quality systems to support the creation, management, and maintenance of Device Quality Management System (QMS) records while ensuring compliance with FDA and international regulatory standards. Key Responsibilities: Manage Device QMS records including complaints, deviations, CAPAs, change controls, and auditsEnsure compliance with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDRSupport quality documentation,