Quality Systems Specialist

Execute and support Quality Management System (QMS) remediation activities and corrective action plans in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and company procedures. Develop, review, revise, and maintain controlled quality documentation, including SOPs, Work Instructions, Forms, and Templates. Monitor remediation progress, provide timely updates to management, and assist in harmonizing procedures across departments. Support continuous improvement initiatives and ensure audit readiness for Internal, Supplier, Customer, FDA, Notified Body, and MDSAP audits. Assist with Change Requests, Complaint Monitoring, and Deviation Management. Work closely with cross-functional teams to ensure documentation accuracy and effective implementation of quality system requirements.