Are you passionate about quality and compliance in the medical device industry? Join our team as a Quality Management System Coordinator and play a key role in ensuring our systems meet top regulatory standards like ISO 13485 and 21 CFR 820. We're looking for a detail-oriented professional with strong knowledge of QMS processes and a drive for continuous improvement. If you're ready to guide teams, monitor critical quality activities, and support our mission of excellence, this could be your next big opportunity. Primary Responsibilities Coordinate and keep the QMS updated per ISO 13485, 21 CFR 820, 29 CFR 1910, and applicable regulatory requirements. Ensure that the processes and procedures necessary for the quality management system are established, implemented, and maintained. Direct and monitor complaints/suggestions. Guide staff on the Quality Management System, advise on the construction of documents, raising non-conformities, construction of action plans, and corrective and preventive actions. Monitor the effectiveness of the actions originating from: Postmarket Surveillance, internal and external audits, and Management Review Meetings. Requirements: US Visa Professional in Biomedical Engineering or related careers. 1 year in related positions Knowledge of ISO 13485:2016 Desired: Knowledge of 21 CFR 820 Place: Seniority level Entry level Employment type Full-time Job function Quality Assurance Industries Medical Equipment Manufacturing #J-18808-Ljbffr