Position Overview
Key Responsibilities:
Support implementation of internal quality system requirements and external regulatory standards (e.g., FDA, ISO 13485, cGMP, EU MDR)Drive improvements to procedures and standards to enhance efficiency while maintaining complianceSupport and coordinate CAPA and compliance programs, including facilitating CAPA activities across functionsParticipate in CAPA management activities and global quality system discussionsConduct internal audits to identify gaps, ensure compliance, and drive continuous improvementSupport audit readiness, including front-room and back-room activities during external audits and inspectionsDeliver quality system training and guidance to employees across the siteLead or participate in system and process improvement initiatives using structured problem-solving approachesIdentify areas of non-compliance and recommend corre...