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