Junior Quality Engineer

Caristo Diagnostics; Oxford; Vor Ort; GBP 32.000 - 42.000; Vollzeit

Benefits dieser Stelle

Competitive salary

25 holidays per year plus bank hol ida

Enhanced pension contribution

Private medical insurance

Life insurance

Cycle-to-work scheme

Zusammenfassung

Caristo Diagnostics in Oxford, UK, is seeking a Junior Quality Engineer to support the day-to-day administration, maintenance, and compliance of our eQMS within the Quality and Regulatory department. Reporting to the Senior Quality Engineer, you will focus on quality assurance compliance and documentation control for our SaMD platform.

The ideal candidate will have a keen eye for detail, strong organizational skills, and the ability to work methodically in a regulated environment.

Qualifikationen

• Strong understanding of document control and quality records.
• Ability to follow defined procedures, checklists, and SOPs accurately.

Aufgaben

• Support administration and maintenance of the eQMS, quality records, workflows, and compliance documentation.
• Assist with design control activities, including DHF maintenance and IEC 62304-aligned documentation.
• Track non-conformances and CAPAs through to closure, supporting investigations.
• Manage training records, competency evidence, and document control to maintain audit readiness.
• Prepare evidence for ISO 13485, FDA, ISO/IEC 27001, and SOC 2 audits and inspections.

Kenntnisse

Document control

Compliance administration

Ausbildung

Bachelor’s degree

Tools

eQMS

Jobbeschreibung

A fantastic opportunity has become available for a Junior Quality Engineer to join Caristo Diagnostics rapidly growing team. Based in Oxford, you will work in our global data operations team with colleagues in both U.S. and UK.

About Caristo Diagnostics

With the first and only FDA approved (July 29, 2026) coronary artery inflammation diagnostic medical device, CaRi-Heart®, Caristo Diagnostics is a global leader in AI technologies for cardiovascular disease, founded as a spin-out from the University of Oxford in 2018. Caristo also has an FDA approved (2025) coronary artery plaque diagnostic medical device. Its award-winning inflammation technology helps detect hidden heart disease and identify people at risk of a heart attack before symptoms appear allowing for proactive disease management. Working with leading hospitals, research institutions, and pharmaceutical partners, Caristo aims to save lives through early detection and personalized prevention. The company was named a 2026 Technology Pioneer by the World Economic Forum in June 2026. Learn more at www.caristo.com or follow Caristo on LinkedIn, YouTube, and X.

About the CaRi-Heart® Technology

Named first of “7 Technologies That Could Change Heart Healthcare Forevermore” by the Robb Report, the CaRi-Heart® technology is Caristo’s flagship offering which uncovers hidden coronary inflammation, a key driver of cardiovascular disease, on routine Coronary Computed Tomography Angiography (CCTA).

The technology is regulatory approved for clinical use in US, UK, Europe, and Australia and is in use with a growing number of hospitals and clinics. Multiple patents underpinning CaRi-Heart technologies have been granted in major jurisdictions around the world. In addition, exceptional validation results showing CaRi-Heart’s ability to aid the prediction of heart attacks have been published in leading medical journals including the Lancet, JACC, European Heart Journal, and Cardiovascular Research.

About the Role

We are seeking a detail-oriented Junior Quality Engineer to support the day-to-day administration, maintenance, and compliance of our Electronic Quality Management System (EQMS). Reporting directly to the Senior Quality Engineer, your focus will be entirely on quality assurance compliance, documentation control, and adherence to our Software as a Medical Device (SaMD) platform.

The ideal candidate will

• be motivated at the thought of working in an innovative healthcare start-up with a strong collaborative research and operations culture, helping to build a global business that will have material impact on the health and wellbeing of potentially millions of people.
• share the company values of pushing the boundaries, taking ownership, caring for each other and acting with candour and professionalism.

Job Title

Junior Quality Engineer

Department

Quality and Regulatory

Location

Oxford, UK

Responsibilities

• Support administration and maintenance of the eQMS, including quality records, workflows, and compliance documentation.
• Assist with design control activities, including software design reviews, DHF maintenance, and IEC 62304-aligned documentation.
• Track non-conformances and CAPAs through to closure, supporting investigations and root cause documentation.
• Manage training records, competency evidence, and document control activities to maintain audit readiness.
• Help prepare evidence for ISO 13485, FDA, ISO/IEC 27001, and SOC 2 audits and inspections.

Skills & Experience Required

Essential

• Strong understanding of document control, quality records, and compliance administration.
• Ability to follow defined procedures, checklists, and standard operating processes accurately and consistently.

Desirable

• Bachelor’s degree in a scientific, engineering, computer science, or business discipline, or equivalent operational compliance experience.
• Introductory knowledge of medical device software standards, such as IEC 62304.
• Experience in compliance, document control, administrative quality, or use of an eQMS.
• Familiarity with ISO 13485, ISO 27001, SOC 2, or other regulated quality/security frameworks.

Essential Soft Skills

• Exceptional attention to detail and ability to maintain accurate records.
• Clear written communication and ability to produce objective, professional compliance documentation.
• Organised, reliable, and comfortable working methodically in a regulated environment.

Benefits

• Competitive salary
• 25 holidays per year plus bank holidays
• Enhanced pension contribution
• Private medical insurance
• Life insurance
• Cycle-to-work scheme
• Additional benefits for long-service

Why join Caristo

• Be part of a company at the cutting edge of medical technology, with the potential to save lives and revolutionise healthcare
• Join a dynamic and growing team, with opportunities for personal and professional growth
• Contribute to the development of groundbreaking products in a company poised for significant expansion
• Enjoy a supportive and collaborative work environment, with a strong emphasis on innovation, quality, and impact

Caristo Diagnostics is committed to diversity and inclusion, and encourages applications from all qualified candidates, including those making a step up in their career. If you are passionate about making a difference in the world of medical imaging and meet the above criteria, we would love to hear from you.

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