Entrust Resource Solutions are supporting a rapidly growing diagnostic medical device company based in Central Scotland to recruit for a Senior Quality Engineer – Clinical. The successful candidate shall primarily be responsible for supporting the Clinical and Medical Affairs teams both in pre and post-market activities and ensuring that procedures followed are in compliance with ISO 13612 Performance evaluation of in vitro diagnostic medical devices.
To be successful in your application, it is essential that you:
* Have knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.
* Have a scientific background.
* Be able to demonstrate experience of clinical performance evaluations for IVD or Medical Devices
* Have experience of risk management activities.
* Be able to demonstrate experience of working in an IVD or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.
* Have experience of both pre and post launch IVD or medical device activities.
It is highly desirable that you have demonstrable experience of working on regulatory submissions.
If the above requirements resonate with your own experience and you are keen to learn more about the role call Shauny on (phone number removed) or submit your CV to apply.
Job Type: Permanent
To apply for this job please visit www.cv-library.co.uk.