Accountable for Driving & ensuring CAPA compliance of the sites, while driving process effectiveness and efficiency at the site along with Cross Functional Team. Provide leadership and coaching for the Quality team, ensuring timeliness of CAPA record closures. Support as CAPA expert in both external and internal audits. Manage CAPA metrics at site & report to Leadership.

Experience in Software & Hardware Medical device industry with special emphasis on Process Engineering, Project Management and Quality Assurance, handling the regulatory & standard requirements of various countries across globe. Experienced in internal & external audits including FDA, MDSAP , ISO audits etc.Medical device(software+hardware) Design Specification site QA approving the required medical regulation deliverable & managing the project execution in a compliant way. Deals with post… Show more Experience in Software & Hardware Medical device industry with special emphasis on Process Engineering, Project Management and Quality Assurance, handling the regulatory & standard requirements of various countries across globe. Experienced in internal & external audits including FDA, MDSAP , ISO audits etc.Medical device(software+hardware) Design Specification site QA approving the required medical regulation deliverable & managing the project execution in a compliant way. Deals with post market complaint management & related investigation. Show less