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Senior Quality Specialist
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Senior Quality Specialist | ISO 13485 | IVDR | Guildford
You are a quality professional who enjoys being close to the action. You like building, improving and owning quality systems rather than simply maintaining them.
You want to work in an environment where your expertise is genuinely valued, where you can influence the direction of the business, and where there is real opportunity to step up, develop new skills and take ownership of critical quality activities.
We're partnering with a growing diagnostics company developing innovative liquid biopsy and diagnostic technologies. As the business prepares for a critical ISO 13485 recertification in December, they are looking for an experienced Senior Quality Specialist who can immediately make an impact and help strengthen the organisation's quality foundations.
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THE ROLE
This is a highly visible, hands-on quality position with direct access to senior leadership.
Reporting to the CEO, with a dotted line into the Chief of Staff, you will take ownership of key aspects of the Quality Management System and drive improvement initiatives across the organisation.
Key responsibilities include:
- Support and continuously improve the ISO 13485 Quality Management System
- Lead document control, CAPA, change control and non-conformance activities
- Support IVDR, UKCA and broader regulatory compliance initiatives
- Coordinate internal and external audits
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ABOUT YOU
You will bring:
- 5+ years' experience within the medical device and/or IVD industry
- Deep knowledge of ISO 13485
- Experience supporting audits and inspections
Desirable:
- Experience with IVDR
IMPORTANT
Due to the urgency of this hire:
Candidates with more than one month's notice period will not be considered
LOCATION
Guildford
If you are looking for a role where you can take ownership, increase your visibility, work closely with senior leadership and accelerate your career in quality, we'd love to speak with you.
Apply now.
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