Primary job duties will include:
Hands on experience in Risk management(DFMEA, PFMEA, risk analysis) , Analytics/statistical techniques, Requirements management, Verification & Validation.
• Hands on experience in Medical device Quality Management system (QMS)
• Design control across the lifecycle of the product.
• Review & update QMS procedures
• Work in areas like CAPA, Non-conformances & complaints
• Working knowledge in ISO 13485 & 14971
• Develop Quality and process cost improvement activities.
• Develop review and approvals for the release of product changes ensuring quality requirements are met.
• Develop verification and validation strategies for end to end process validation.
• Document Management and Engineering Change management
• Post Market Surveillance activities