Quality Engineer - Medical Devices
- Full Time
We are seeking a proactive individual with experience of medical device design in a regulated environment to join our team and assist in the translation of our research. This is an exciting opportunity to design and implement flexible and agile quality assurance design and development processes to meet the varied requirements of academic research projects as they progress along the translational pathway. The Quality Engineer will work with project teams on state-of-the-art technology in collaboration with clinicians and engineers in a clinical academic setting.
The primary role of the post holder will be to work with groups in the CME to ensure the design of medical devices meets required regulatory, quality and safety standards for transfer to the clinic to be used in first-in-human studies and follow-up clinical investigations. The post holder will be expected to guide project teams by identifying gaps in information and processes; recommending solutions, and be responsible for setting standards and developing procedures that meet the needs of different groups across the CME in research and prototyping activities.
The individual will help establish and maintain a Quality Management System (QMS) and act as the quality lead for medical device and hardware design control processes.