Quality Systems Specialist

We are seeking a Senior Quality Systems Specialist who will be responsible for supporting and executing the Quality Management System (QMS) Remediation Plan in compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), EU MDR 2017/745, applicable regulatory requirements, and company procedures.

The Senior Quality Systems Specialist works closely with cross-functional teams to ensure documentation accuracy, regulatory compliance, and the effective implementation and maintenance of quality system requirements.

• Execute and support QMS remediation activities and corrective action plans.
• Ensure Quality System processes comply with applicable regulatory requirements, company policies, and industry standards.
• Develop, review, revise, and maintain controlled quality documentation, including SOPs, Work Instructions, Forms, and Templates.
• Monitor remediation progress and provide timely updates to management.
• Support continuous improvement initiatives by identifying opportunities to enhance processes and increase efficiency while maintaining compliance.
• Assist in harmonizing procedures and implementing quality best practices across departments.
• Provide support during Internal, Supplier, Customer, FDA, Notified Body, and MDSAP audits.
• Ensure audit readiness by maintaining accurate documentation and supporting responses to audit observations and findings.
• Assist with Change Requests (CRs), Complaint Monitoring, and Deviation Management activities as needed.