Quality Engineer

If you’re used to stepping into a fully built QMS with clear processes, and everything neatly in place, this probably isn’t for you. But if you enjoy getting stuck into the reality of how a medical device actually gets to market, keep reading. I’m working with an early stage Medical Device company based in London.

They’re pre commercial, with a Class II/III product, targeting US entry by the end of this year. This isn’t just maintaining a system, instead you’ll be right in the middle of getting this product ready for market. That includes: • Owning CAPA, NCs, and root cause investigations • Managing change control across product and process • Supporting process validation (with fully outsourced manufacturing) • Working closely with suppliers • Building and improving parts of the QMS as the business scales • Supporting internal and external audits • Helping shape final QA release processes You’ll also be close to key milestones like: → 510(k) submission → ISO 13485 certification → Supplier audit programmes → Product launch For this role to land, the business needs someone who understands manufacturing quality in medical devices.

You’ll likely have: • Experience in Class II/III medical devices • Exposure to ISO 13485 and ideally 21 CFR 820 • Strong CAPA, root cause, and change control experience • Experience working with suppliers or outsourced manufacturing If you’ve worked in a smaller or scaling environment before, that’s a big plus. If you’re someone who enjoys being in the detail but also wants to make a genuine impact, this is a really interesting one. Message me directly or apply below and I’ll talk you through the full picture.