Quality Assurance Engineer
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
Über die Firma
