Quality Engineer

Quality Engineer

Work Flexibility: Hybrid

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 

What you will need-

Required Skills-

• Education -BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
• Experience- 2 years - 5 years ; relevant experience of 1-3 years of experience in Medical Device domain
• 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.

Preferred Skills-

• 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/ Microsoft office Word & Excel

 

Travel Percentage: None

Experience Level

Mid Level