Product Quality Engineer

OrganOx is seeking a Product Quality Engineer to oversee device inspection and acceptance activities for their OrganOx Metra class III medical device. This role involves leading quality inspection processes, conducting investigations, leading continuous improvement initiatives, and ensuring adherence to regulatory standards. The position requires hands-on experience in quality engineering and a proactive approach to process improvement.

Requirements

• 2-5 years of related quality engineering work experience
• Knowledge of regulatory and quality standards (FDA QSR, ISO 13485, EU MDR)
• Ability to travel internationally (up to 30%)
• Demonstrable technical quality engineering skills
• Experience with nonconformances, CAPAs, and SCARs
• Bachelor’s degree in Engineering, Life Sciences, or a related technical field

Benefits

• Competitive compensation
• Comprehensive benefits
• Healthcare
• Retirement plans
• Work-life balance support
• Opportunities for professional development