Quality Assurance Engineer

What You Will Do-

• 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; 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
  

Required-

What you will need-

• BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
• experience- 2years 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