Quality Engineer - Medical Devices

Quality Engineer Work Flexibility: Hybrid What you will do- Investigates & document customer complaints according to applicable regulatory requirements and products. Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints. Proactive collaboration with cross functional team members to get resolution on customer complaints. Timely closure of customer complaints Collaborates effectively with cross functional and divisional partners to achieve goals. Effectively adapts style in global interactions accordingly. Develop understanding of Stryker products and processes What you will need- Required Skills- Education -BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes Experience- 2 years - 5 years ; relevant experience of 1-3 years of experience in Medical Device domain At least 2+ years of experience in complaint handling or customer quality. Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations; u nderstanding on Medical Device Risk Management Hands-on Experience on Complaint handling and Product investigations of medical devices. Preferred Skills- Experience on root cause analysis of field returned products. Understanding on NC CAPA process. Knowledge of various quality tools. Tools - TrackWise complaint handling tool or equivalent/ Microsoft office Word & Excel Travel Percentage: None Experience Level Mid Level