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.
