OrganOx Technology Transfer Specialist

Contribute to innovative medical solutions as a Technology Transfer Specialist at OrganOx in Oxford. This role emphasizes process changes and regulatory compliance. In this position, you will oversee project management related to the change control process while ensuring all operations meet regulatory standards like FDA and ISO. Your skills in medical device manufacturing and cross-functional teamwork will be crucial in updating key processes. You will be actively involved in risk mitigation strategies and provide regular project updates to stakeholders. Key Responsibilities:

• Manage change control and project activities end-to-end
• Develop and implement process validation plans
• Create and update Standard Operating Procedures
• Assist with regulatory submissions and documentation
• Support Root Cause Analysis and issue resolution

• Experience in project and change management in medical devices
• Educational background in process or mechanical engineering
• Knowledge of QMS and regulatory compliance
• Familiar with Lean or Six Sigma methodologies
• Ability to manage multiple priorities effectively