💼 About This Role

You'll lead quality engineering projects for medical device manufacturing, ensuring products meet regulatory and industry standards. You'll develop and implement inspection methods and drive continuous improvement. This role offers exposure to FDA audits and working with electromechanical medical devices.

🎯 What You'll Do

• Participate in development and qualification of new and existing products
• Design and implement methods for inspecting, testing, and evaluating equipment
• Monitor design control and assure compliance with regulatory standards
• Support FDA inspections and notified body audits

📋 Requirements

• Bachelor's degree in Engineering or Life Science with 5+ years quality experience
• Experience in Quality Assurance and ISO
• Experience in a medical device or regulated industry
• Experience with PFMEA and Change Control

✨ Nice to Have

• Advanced degree preferred
• Experience applying IEC 60601 standards
• Experience with electronic devices or PCBAs