QE (NCS/Job/ 4004)

Design Quality & Complaint Handling Engineer
Job Description
Position Summary
We are seeking an experienced Design Quality & Complaint Handling Engineer to support product
quality throughout the product lifecycle—from design and development through post-market
surveillance and complaint investigations. The role requires close collaboration with R&D;,
Manufacturing, Regulatory Affairs, and Quality teams to ensure compliance with global medical
device regulations.
Key Responsibilities
Design Quality
• Support Design Controls, Design Reviews, DHF/DMR documentation, and Design Verification &
Validation (DV&V;).
• Execute Risk Management activities in accordance with ISO 14971.
• Support New Product Introduction (NPI), design changes, and engineering change control.
Complaint Handling
• Investigate customer complaints and returned medical devices.
• Perform root cause analysis and prepare investigation reports.
• Identify complaint trends and recommend CAPA.
Quality & Compliance
• Manage CAPA, non-conformances, process improvements, and audit readiness.
• Support Post-Market Surveillance (PMS) and Regulatory Affairs activities.
• Maintain compliance with ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Part 820.
Required Technical Skills
• Design Quality Engineering
• Complaint Investigation
• Medical Device Failure Analysis
• Root Cause Analysis (5 Why, Fishbone, 8D)
• CAPA & Non-Conformance Management
• Risk Management (ISO 14971)
• Engineering Drawing Interpretation
• Mechanical Fundamentals
• Statistical Analysis & Quality Tools
• Process Validation (IQ/OQ/PQ)
• Design Verification & Validation (DV&V;)
• Change Control
• Product Lifecycle Management
Qualifications
• B.E./B.Tech/M.Tech in Mechanical, Biomedical, Medical Electronics, or related Engineering.
• 4–8 years of experience in Medical Device Design Quality, Complaint Handling, Quality
Assurance, or Regulatory Affairs.
Preferred Knowledge
ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDR, Design Controls (DHF/DMR)