If you’ve been a Quality Engineer in a structured medical device business and you’re ready to actually shape how a quality function runs from the ground up, read on.
A MedTech scale up in London are building a Class III orthopaedic implant with FDA clearance targeted for end of 2026 and ISO 13485 certification planned for Q4 2026.
Production is fully sub-contracted, so supplier quality sits right at the heart of this role.
**Why this role is worth your time:**
You’ll own a real chunk of the QA function, not a slice. Supplier quality, process validation, document control, NC/CAPA, change control, internal audits, and establishing the companies final QA release process from scratch. It’s all yours for the taking.
You’ll join immediately before an FDA submission. Few QEs get to be in the room when a Class III device goes through this milestone.
You’ll work directly with the Global Head of RA/QA, with full access to the engineering team and CTO every day.
Your work will be visible and attributed to you, not buried under corporate layers.
The company funds training and external mentoring for every person on the team.
Serious investment is lined up post-FDA approval, with a clear pipeline of products beyond this first device and more hires to come.
**The honest bit:**
This is a small startup pre revenue. Two huge milestones (510(k) and ISO certification) land in the same year. One key US based supplier eats around 60% of your supplier management time, and you’ll need to be comfortable holding them to account, including occasional travel to the US for audits. There are no perfect systems to inherit, instead you’re shaping them.
**What they’re looking for:**
Class IIb or III experience.
ISO 13485 and 21 CFR 820 background.
Sterile products.
You’ll have worked at a legal manufacturer or as a sub-contractor to one.
Solid on process validation, change control, NC/CAPA, root cause investigation, and internal/external audits.
Comfortable reading drawings (GD&T) at a working level so you can challenge suppliers.
Engineering background or engineer turned QA is a real plus.
Not for you if you’ve only worked at a virtual manufacturer or kit packer.
Sound like the next step for you? Click apply and I will be in touch.
