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 compliance
Support and coordinate CAPA and compliance programs, including facilitating CAPA activities across functions
Participate in CAPA management activities and global quality system discussions
Conduct internal audits to identify gaps, ensure compliance, and drive continuous improvement
Support audit readiness, including front-room and back-room activities during external audits and inspections
Deliver quality system training and guidance to employees across the site
Lead or participate in system and process improvement initiatives using structured problem-solving approaches
Identify areas of non-compliance and recommend corrective actions to improve overall quality system effectiveness
Provide quality...