Senior Quality Engineer- Design Quality – Lifecycle Management

📋 Description

• QA lead for design transfer and change management in medical devices and combination products.
• Represent QA on cross-functional teams; ensure regulatory compliance worldwide.

🎯 Requirements

• Bachelor’s degree in engineering, science or technical field
• 6+ years in medical device, 4+ years QA experience
• Regulatory knowledge: 21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971
• Design Control per 21 CFR 820.30; risk management and design change control
• Strong communication, leadership, and cross-cultural collaboration
• Product development experience and design history file/risk management oversight

🎁 Benefits

• Not specified in description