Quality Assurance Engineer

2 months ago

Gurugram, India Stryker Global Technology Center Pvt Ltd. Full time
Work Flexibility: Hybrid

Post Market Surveillance - Customer Quality Engineer

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 Communicate and Collaborates effectively with cross functional and divisional partners located gloabally to achieve goals. Effectively adapts style in global interactions accordingly. Develop understanding of Stryker products and processes 

Experience and Skill Needed :-

BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes 2-6 years of experience in Medical Device domain preferred 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 Understanding on Medical Device Risk Management Hands-on Experience on Complaint handling and Product investigations of medical devices. 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 Salesforce Microsoft office Word & Excel Travel Percentage: None

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