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Quality Assurance Manager
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About the Role
We're working with an early stage IVD company in Oxfordshire that needs someone to come in and build their quality system from the ground up.
At least 3 days a week on-site in Oxfordshire and paying between £60,000-£80,000 DOE.
They've got a working prototype, a small team of scientists and engineers, and a pilot clinical study about to start. What they don't have is a QMS. Gap assessment, pick and roll out the eQMS, write the procedures, train the team, get them through ISO 13485 in the next 15–18 months and then move on to IVDR and FDA submissions off the back of it.
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You'd be reporting to a COO who has taken an IVD from concept to market before and knows what good looks like. He'll back you but he needs someone who owns it and will hold the line when the pressure's on, this isn't a role for someone who defers.
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What they need:
- IVD experience. Devices as well is great but there has to be IVD in there
- 5+ years in and around ISO 13485, ideally having built or substantially rebuilt a QMS rather than just maintained one
- Solid on 14971, IVDR, 21 CFR 820
- Hands on with eQMS, ideally having been part of choosing one
- CSV / software validation, IQ OQ PQ, you'll be validating their tools
- Comfortable in a start up where the swim lanes don't exist yet, one minute it's the NC procedure, the next it's a supplier audit
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