Quality Sys Spec II

The Quality System Specialist supports and performs activities associated with processes that make up the Quality Management System (QMS). This includes but is not limited to change control, CAPA, audit (internal/external) and management review meeting. How You'll Make An Impact Manage the change request process, ensure timely review and arrange change control meetings to review changes related to design, manufacturing processes, product design and documentation. Collaborate with internal stakeholders (e.g., Manufacturing Engineering, Quality Control, Value Engineering) and external stakeholders (e.g., R&D, Regulatory Affairs) to assess change impact and ensure alignment. Support and co-manage the Corrective and Preventive Action (CAPA) process with CAPA owners, ensuring root cause analysis, action plan development & execution and effectiveness checks, and timely closure. Prepare and organize materials for periodic management review meetings in accordance with ISO 13485:2016. Coordinat...