Cure Talent
Quality Assurance Manager
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Cure Talent are delighted to be partnered with a specialist medical device manufacturer whose portable neonatal incubators are deployed in some of the world's most challenging environments, from emergency responses in active conflict zones to hospitals across multiple international markets including the US and Australia. It is a business with a clear social purpose and serious commercial momentum, having grown sales by more than 10x year-on-year.
FDA-cleared and scaling fast, the team is small, pragmatic, and genuinely committed to the work they do. This is not a corporate quality role.
The Opportunity
As Quality Manager, you will take full ownership of day-to-day quality operations and play a central role in maintaining and developing the ISO 13485 QMS as the business scales. You will work closely with the leadership team, manage document control and batch record release, lead internal audits, and support regulatory activity across the business.
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The role is based primarily on-site in Stevenage, Hertfordshire, with one day per week working from home.
This role comes with a defined pathway for growth. For the right person, there is a genuine opportunity to broaden into regulatory affairs and progress toward a senior regulatory leadership position, including potential PRRC responsibility, as the business continues to develop.
What We're Looking For
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- Proven quality management experience in medical devices
- Strong ISO 13485 knowledge, including hands-on QMS development and maintenance
- Internal audit experience, with a solid grasp of document control, CAPA management, and non-conformance handling
- Comfortable working in a paper-free eQMS environment
- An interest in regulatory affairs and the ambition to grow into it
- A practical, roll-your-sleeves-up mindset suited to a fast-moving SME
Why This Role
A rare chance to join a mission-led MedTech business at a pivotal point in its growth, with genuine influence over quality operations from day one and a clear pathway toward senior regulatory responsibility.
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