Quality Management Specialist

Job description

Job Description: The Quality Management Specialist is responsible to support the continuous improvement, compliance, monitoring, and harmonization of an integrated medical device Global Quality Management System applicable to the Nobel Biocare Group (with focus on quality and operations related processes), and to support different Life Cycle Management activities to ensure compliant execution. Create, update, and maintain QA documentation in accordance with approved procedures and regulatory requirements (e.g., ISO 13485, FDA QSR). Perform document control activities, including review, approval coordination, issuance, revision, and archiving per QMS requirements. Ensure accuracy, completeness, and compliance of controlled documents following GDocP. Support training record management and timely completion of required QMS training. Coordinate and support Change Requests, ensuring timely processing, execution, and closure. Prepare, review, and verify change documentation for completeness, quality, and regulatory compliance prior to release. Maintain and control change-related documentation and technical data in SAP DMS in accordance with QMS and GDocP. Organize and chair Change Approv...