§ To assure & review quality system and to ensure the compliance with established standards. § Ensure effective implementation of systems and procedures as per cGMP, GLP, ISO 13485 and other regulatory/customer requirements. § Participate in risk assessment, provide risk-assessment tracking and other established mechanisms for risk assessment. § Handling of various QMS related software’s like TrackWise, ENSUR and SAP. § To represent QA department in external and internal audits in...