Member Of Technical Staff In Qa And Qc
Current• Responsible for QMS management(ISO 13485:2016), regulatory review for product and process, quality control for the product and risk management for products designed & developed• Certified auditor for medical devices QMS and actively part of internal & external audits• Responsible for design verification & validation protocols & their management (Especially devices) • Risk & change management through out product lifecycle • Handling & managing product evaluations for safety compliance & regulatory requirements• Involved in Quality policy management & continuum improvements of both process & product