Quality Engineer

Overview

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.

Responsibilities

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

Milestones

You’ll also be close to key milestones like:

Qualifications

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.

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