Job Description
Key Responsibilities:
- Ensure compliance with internal quality systems and external regulatory requirements (e.g., FDA, ISO 13485, cGMP, EU MDR and other applicable standards)
- Lead and support external inspections and regulatory audits
- Plan, coordinate, and conduct internal audits, including identifying gaps, investigating findings, and driving corrective actions
- Identify areas of non-compliance and drive continuous improvement initiatives
- Act as subject matter expert (SME) for CAPA processes, ensuring effective implementation and timely closure
- Maintain and continuously improve site CAPA processes and systems
- Develop, track, and report CAPA metrics to support management review activities
- Support corrective and preventive action processes across the site
- Collaborate cross-functionally to standardize quality system policies and procedures
- Provide training and guidance to teams on qualit...