Quality Assurance Engineer
Stryker
Customer Complaint Investigator
Work Flexibility: Hybrid
What you will do:
Investigates & documents 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:
BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
Experience: 2 years to 6 years
At least 2+ years of experience in complaint handling or customer quality and TrackWise complaint handling tool or equivalent
Preferred:
Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations; 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 and knowledge of various quality tools.
Understanding on NC CAPA process
Travel Percentage: None