Quality Manager
Are you an experienced quality leader with a background in medical devices or IVDs, looking to take ownership of global quality systems in a pioneering life sciences organisation? This is an opportunity to play a critical role in driving compliance and inspection readiness within a high-growth company.
The Company
This innovative organisation is at the forefront of precision medicine, developing advanced liquid biopsy technology that transforms the way cancer is detected and monitored. With a strong focus on regulatory compliance and continuous improvement, their quality team underpins the delivery of safe, effective, and innovative products. The business is growing rapidly, offering the chance to make a tangible impact in a collaborative and mission-driven environment.
THE ROLE
As Quality Manager, you will be responsible for overseeing all aspects of the quality management system (QMS), product and process assurance, and design/software quality. You will lead a team of quality professionals, ensuring compliance with ISO13485, IVDR, and FDA QMSR standards while maintaining certification and regulatory readiness. Your role will span supplier quality, audits, product release, and non-conformance management, while acting as a deputy PRRC and QMS representative. This is a leadership role where you'll embed a culture of quality across the organisation and champion continuous improvement.
About You
You'll thrive in this role if you bring:
* 8+ years' experience managing QMS in medical devices, ideally with IVD manufacturing exposure.
* Proven experience hosting and leading audits with regulatory authorities and notified bodies.
* Strong knowledge of ISO13485, IVDR, and FDA QMSR requirements.
* Familiarity with software standards (IEC 62304, GAMP5, 21CFR Part 11).
* People management experience, with the ability to develop and motivate teams.
If this sounds like your next career move, apply now.
I look forward to hearing from you