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Quality Engineer

Gurugram, IndiaPosted 2 days ago
Full-timehybrid

Job Description

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

Quality Engineer at Stryker | Renata