Assistant Manager
Current• Ensure the QMS 9001:2015, 13485:2016 for Medical device is implemented and effective within organization.• Responsible for analysis and provide the action plan for customer complaint received from market.• To verify inward material & finish good product inspection is as per specification and followed ISO 2859-I sampling plan.• Responsible for plan and execution of internal & external audit and to close the audit non-conformity within timeline.• Handling calibration of equipment in order to maintain equipment as per NABL/Government standard.• Ensure the SOP’s, formats used in the plant is controlled copy.Responsible for monitoring and measurement of CAPA effectiveness.• Verify the calibration of all the instruments use for quality testing and on production lines.• Responsible to prepare, review and update the management review meeting, quality manual, site master file, SOP’s, Quality plan, Inspection plan, test methods etc as per requirement.• To ensure the effectively execution of trainings, 5’s as per monthly plan.• Handle the customer complaint with root cause analysis and CAPA.• Ensure the BMR is correct and completed before batch release.