Senior Staff Design Quality Engineer

📋 Description

• Provide technical leadership for Design Quality Engineering across the medical device lifecycle.
• Represent Quality on product/process development teams; integrate quality requirements into
• Ensure design control activities: verification, validation, risk mgmt, design reviews, and DHF.
• Lead or support supplier quality activities; PPAP review; inspection planning.
• Work with engineering to define quality characteristics and inspection plans.
• Lead investigations, root-cause analysis, and corrective actions for complex problems.

🎯 Requirements

• Bachelor’s in Engineering with 10+ years in medical device quality engineering, or Master’s with 8+
• Extensive medical device product development experience; QMS (FDA 21 CFR Part 820, ISO 13485, EU
• Design controls, V&V, risk management per ISO 14971; FMEA and Hazard Analysis experience.
• Experience with Change Control, Non-conformance, CAPAs, HHEs; strong analytical and communication
• Proficiency in English; advanced Microsoft Office skills; ability to work cross-functionally.
• Knowledge of IEC 62304 and other ISO standards is preferred; experience in women’s health devices

🎁 Benefits

• Remote work based in India (Gurgaon/Haryana location referenced).
• Senior technical ownership and SME status in Design Quality Engineering.
• Professional growth through exposure to advanced medical device quality, regulatory, risk
• Leadership opportunities to mentor engineers and drive cross-functional initiatives.
• Cross-functional collaboration with R&D, Operations, Regulatory, Clinical, and Manufacturing.