• 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.

Responsible for connect Compliances, Product Documentation, final inspection, SPA ,New product developments, packaging developments.Good knowledge about the requirements for Children articles, Food contact/Kitchen articles and other home furnishing products.

Implement and maintain Quality Systems that are in compliance with various quality standards and regulations.• compliance to technical dockets and effectiveness of corrective & preventive actions.• Follow and implement ISO9001, Quality Management Systems in sprit.• Preparing inspection check list for online components and ensure that the critical dimensions are under specification.• Try to disposal of N.C. product.• Continual Improvements.• Cost of Quality.• Training to sub-ordinates and floor workers as per schedule.• Establish and maintain policy for documentation of all products.• MIQS report of the department.• Analysis of rejection at different level of production and take corrective actions on daily rejections,• Coordinate with Design for BOM preparation during the proto stage and ensure the material is consumed as per BOM during the production stage.• Maintaining vendor rating as per receiving inspection standards for the bought-out parts.• Supplier Audit & Up-gradation• To monitor the productivity and quality.• Prepare process flow, SOP, Work instructions for each model and continuously update.• To ensure that the manufactured products or components are of consistent quality.• Develop multiskilling of the operators.• To measure the cycle times of the operations and reduce the cycle time where possible.• Coordinate with stores for materials and feeder departments for timely completion of production.• Preparing CAPA for Rejection/ Complaint.• Involve in Testing like MFI, ESCR, VSP/HDT, Impact test, Salt Test (NaCl2), Load Test, Izod Impact test, Torque test and Product like Drop, Performance test, Leakage in Vibration Test, Mechanical and Chemical properties, B.S, GSM etc.