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