If you work in Quality Assurance and have been waiting for a Medical Device business where you can genuinely take ownership of how the quality system runs and grows, this is the role.
A privately owned UK Medical Device company with around ten people and a portfolio that spans Class I and Class IIa products are looking to make their second hire within their Quality Team.
Reporting directly to the Head of Medical Devices who has run the ISO 13485 QMS himself for six years and is now hiring a QA Specialist/Officer to take it on. This will become your system to own and what a system it is, having just passed recertification audit with zero majors and zero minors!
What is in it for you?
The company are open to two levels.
Someone with a few years of experience looking to take on more responsibility across QA. Where they can learn more basics and work up to taking full QMS ownership.
Or someone who is a little more senior and has been craving a bigger piece of the pie when it comes to quality.
They offer hybrid working, with the kind of flexibility that lets people drop kids off, log back on, and live a life.
There’s also an EU MDR transition and a potential eQMS project sitting in the pipeline, so the scope grows with you.
What we are looking for.
Solid ISO 13485 experience in Medical Devices.
The confidence to own a QMS day to day.
Audit experience is helpful, not essential, you can be trained.
The personality to handle external auditors, suppliers and internal stakeholders.
The kind of person who will thrive here is comfortable in a small, growing business, happy to muck in, and confident enough to say “I have got this” and mean it.
