Medibeam
Quality System Manager
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Most QA Manager roles I see are either buried in a huge team where your work disappears, or so narrow you only ever touch one corner of the system.
And if you have spent years working inside someone else's Quality Management System and you are ready to run your own, then I'd really recommend this role.
About the Role
This is a Quality Assurance Manager role with a Medical Device manufacturer, a role where you would own the QMS outright, reporting directly to the CEO.
Day to day, you will:
- Maintain and improve the system to ISO 13485 and UK MDR
- Run it in Q-Pulse
- Own CAPA and complaints
- Coordinate internal and supplier audits
- Lead the external audits including ISO surveillance and recertification
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You also produce the metrics and Management Review packs that go to the board.
Team
You'd work closely with Clinical, RA, NPD, Engineering and have a small team of 2 to manage, with a view of helping them progress in their career.
If you want to hide in a big team, this role won't be for you, but if you want your fingerprints on how quality runs across a whole business, it is!
Requirements
- At least five years in a regulated medical device manufacturing environment
- A solid understanding of ISO 13485, and real hands on experience of CAPA, document control, internal auditing and hosting external certification audits.
- Experience with an electronic QMS like Q-Pulse would be lovely too.
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It is worth noting, this position will require someone happy to be site based. With the role requiring four days on site and one from home.
If that sounds like the step up you have been after, apply with an up to date CV and I will be in touch.
NB: Currently, the company can only consider UK applicants with the full right to work.
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