Entrust Resource Solutions are supporting a rapidly growing diagnostic medical device company based in Central Scotland to recruit for a Senior Quality Engineer – Risk Management. The successful candidate will report to the quality manager and be responsible for both pre and post-market risk management activities for the device, working with project teams to support design and development processes. They will ensure compliance to ISO 14971 and apply risk management to device development.
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.
* Can demonstrate experience of Risk Management in an IVD or Medical Device environment
* Have previous 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.
* Are experienced in both pre- and post-launch IVD or medical device activities.
* Have a scientific background.
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.