Quality Auditor
Job Fit Check
Base Career helps you apply smarter for this job.
Key skills for this role
Role Overview
As a Quality Auditor at Scarlet, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in Scarlet’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.
Key Skills for This Role
Full Job Posting
We pull medical technology from the future to solve human health.
Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.
Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.
About the role
As a Quality Auditor at Scarlet, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in Scarlet’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.
Responsibilities
- Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements.
- Review records and interview teams to assess whether their processes meet the requirements.
- Document evidence, findings and conclusions in clear, timely audit reports.
- Explain findings constructively and keep customers informed throughout the audit.
- Review corrective actions and the evidence needed to close findings.
Required qualifications
- A degree in a relevant scientific, engineering or medical discipline.
- At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.
- Working knowledge of EU MDR or UK MDR requirements for quality management systems.
- Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation.
- Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment.
Preferred qualifications
- Experience conducting audits for a certification or notified body.
- Experience with medical device software.
Interview process
Introductory call with Sandy — 30 minutes.
QMS audit exercise and discussion with Felicia — 60 minutes.
Culture and values interviews with James and Jamie — 30 minutes each.
References and offer.
About Scarlet
UK medical-device certification body helping software and AI medical-device manufacturers reach market.
Visit company websiteJobs and hiring trendsApply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Scarlet
Software Engineer
, UAE
We pull medical technology from the future to solve human health. Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigoro
Medical Device Auditor
, UAE
We pull medical technology from the future to solve human health. Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigoro
Lead Auditor - Contractor role
, UAE
We pull medical technology from the future to solve human health. Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigoro
Software Engineer
, UAE
Medical Device Auditor
, UAE
Lead Auditor - Contractor role
, UAE
Business Development Representative
London, GBR
Assessment Delivery Optimisation
London, GBR
Clinical Evaluation Specialist
London, GBR
Work at Scarlet
London, GBR
Market Access Operations
London, GBR