Product Quality Engineer

About the role

The Product Quality Engineer will support design controls and quality management associated with the development, transfer and sustaining initiatives for the medical devices. performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues. Transfer Quality deliverables for new products and sustaining projects to manufacturing and operations quality and supplier quality teams.

What you'll do

• Lead all quality elements of Design Controls and product Design History Files
• Lead Quality Plan initiatives associated with Risk Management and Quality System integration
• Analyze situations/data using engineering principles and collaboration to identify gaps between project work and QMS
• Transfer Quality deliverables for new products and sustaining projects to manufacturing and operations quality and supplier quality teams

What you need

• 8–10 yrs of experience
• ISO 9001
• Six Sigma
• Mechanical engineering
• Regulatory affairs
• B.Tech or B.E. or M.Tech

Good to have

• Root cause analysis