Job Description
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 impro...