Key Responsibilities
Perform product quality analysis, inspection, and disposition activities. Investigate and document quality issues using systems such as customer complaints and nonconformance reports. Partner with manufacturing and site personnel to conduct root cause investigations and implement corrective actions. Support and maintain quality management system (QMS) processes, including workflow tracking, metrics, and reporting. Assist with training of support personnel on quality procedures and system requirements. Ensure compliance with applicable regulations including FDA QSR, ISO 13485, CMDR, and MDSAP requirements. Prepare documentation and reports for management review as needed