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.

Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.

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. xwzovoh

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.