Most QA roles fall into two camps: heavy QMS documentation or design focused, but this isn't either.
I’m working with a diagnostics company with a live product already on the market.
The challenge isn’t getting the product approved but keeping control as things evolve.
They’re constantly making changes to materials, components and suppliers driven by cost and performance.
Right now, not all of that change is being properly tracked and that’s where this role comes in.
The business need someone who understands how product changes actually happen in the real world.
It’s hands-on:
* owning and driving change controls
* CAPA / non-conformance investigations
* reviewing and building risk documentation (FMEA etc.)
* working closely with engineers and contract manufacturers
* making sure what’s happening in reality is reflected in the QMS
* pushing things through when they stall
There’s a lot of visibility in this role as you’ll be working directly with engineers, CMOs and senior people in the business, so your impact is seen pretty quickly.
There’s also scope to move into more senior QE/supplier quality leadership or into a broader QA/quality management role.
And because the environment isn’t overly structured, you’ll learn fast which is what tends to accelerate people’s careers.
Background isn’t a blocker here.
You could be coming from medical devices, diagnostics, pharma, automotive or aerospace.
What matters is you’ve worked on a real product and have seen what happens when things change and you’ve been involved in managing that properly.
Message me if you want to take a look.
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