Senior Quality Specialist

Senior Quality Specialist | (SaMD) | Hybrid Central London, 2 days |

If you work in medical device quality and spend your days on one slice of the QMS while someone else gets the interesting bits, this is the role where you get the lot.

My client is a London health tech business with around 30 people. They recently achieved ISO 13485, and with funding secured they're now extending the platform into a Class II software medical device.

Right now across QARA there is one person running it all, and with lots of large projects underway, they need someone to be the right hand on quality.

Day to day you'd own the NC and CAPA process, running the tracking and helping colleagues get root cause analysis right. You'd review and sign off release documentation for software updates, checking V&V reports and whether the testing really covers what changed.

You'd keep the technical file current and get stuck into management review and quality KPIs as you settle in.

The QMS is managed through workflow tools rather than a dedicated eQMS right now, so you’ll need to be comfortable working with a practical, less polished setup.

There's also the ability to touch on RA too, however they do currently have a consultancy supporting with this, so it's more as the company grow that this could become a larger part of the role.

And given the business are on the road to device classification, the device scope is still being shaped, so priorities will shift. If you like figuring things out and finding the practical, compliant route, you'll enjoy that. If you need everything laid out for you, it won't suit.

One of the best parts of this role and company is that a growth plan is already set.

As the device programme builds, there's a real route towards managing the function.

What they'd like to see:

• Software as a medical device experience (SaMD)
• Hands on work with product and engineering on software releases and V&V
• Ownership of part of a QMS, ideally NC and CAPA
• Class II experience is a bonus, and smaller company experience helps

It's hybrid, 2 days a week in Central London, with 30 days holiday plus bank holidays.

Apply with an up to date CV and I'll be in touch, or drop me a message first if you'd like to talk it through.