The Quality Management System (QMS) Specialist will be responsible for developing, implementing, maintaining, and improving the company’s Quality Management System (QMS). This role ensures that the QMS is compliant with ISO 13485, ISO 9001, 21 CFR 820, and 21 CFR 58. The QMS Specialist will support cross-functional teams in achieving quality objectives, ensure continuous process improvement, and maintain high standards for product quality and safety.Key Responsibilities:1. Document Control Management:Oversee the lifecycle of all QMS documentation, including creation, revision, approval, and archiving on electronic QMS.Manage and maintain document control processes, ensuring compliance with applicable standards such as ISO 9001, ISO 13485, and FDA regulations.Ensure that QMS documentation is distributed to the relevant teams and accessible as needed, ensuring proper security and access control.2. Complaint Management – Service LabsAddress customer complaints related to service quality, investigating issues, and collaborating with cross-functional team to provide timely solutions.Manage the repeat testing of samples, ensuring proper documentation and resolution of any quality concerns.3. Cross-Functional SupportProvide training to employees on document control processes, ensuring understanding of proper procedures for document creation, approval, and revisions.Act as a resource for team members regarding document control procedures and QMS documentation standards.Provide support to Project Management team in batch record creation, review, release, and training for special orders.Support Maintenance team in tracking equipment calibration and preventive maintenance logs.Perform quality control testing as needed.4. Audit and Inspection Support:Manage QMS Process Audits to ensure adherence to ISO 13485, ISO 9001, and 21 CFR 820.Assist in preparing for regulatory inspections, ensuring QMS documentation is up-to-date and organized for review.Performs final Quality Control document review prior to product shipment.5. Nonconformance, CAPA, and Change Control Documentation:Maintain and track documentation related to nonconformances, change control, corrective actions, and preventive actions (CAPAs).Ensure CAPA and Change Control documentation is complete and adheres to QMS requirements, supporting timely resolution and verification of actions.6. Reporting and Documentation Metrics:Track key performance metrics related to QMS compliance.Generate reports on document control activities, highlighting key issues, trends, and areas for improvement.
