Knowledge, Skills, and abilities: Strong knowledge of medical device quality systems, site-level QMS controls, DHR/batch records, traceability, WMS or regulated software records, process validation, change control, complaint escalation, recall support, CAPA, nonconformance, and audit/inspection readiness. The position serves as the site's primary quality resource, partnering with operations, customers, and cross-functional teams to ensure product quality, traceability, regulatory compliance, audit readiness, and continuous improvement across medical device operations.