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Medical Device QA Manager jobs

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    • Experience with medical device software.
    • At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485…
    • View all Scarlet jobs - London jobs - Auditor jobs in London
    • Salary Search: Medical Device Auditor salaries in London
    • Proven leadership experience within a regulated manufacturing, medical device, service, or technical environment.
    • Health care and well-being programs.
    • This permanent role will see you play a key part in assessing and improving Quality Management Systems for software-based medical devices.
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    • TRAVEL REQUIRED: Couple of times a year for several weeks at a time, dependent on project and customer needs requirements.
    • TYPE: Full time / STEM returner.
    • Domain: Class III medical device · regulatory affairs.
    • Supporting the development and maintenance of regulatory strategies for Class III medical device…
    • We’re seeking an experienced and motivated Clinical Quality Assurance Manager — a qualified clinician with a minimum of two years’ experience delivering…
    • The UK Affiliate Quality Director is responsible for establishing and maintaining the affiliate Quality Management System and ensuring compliance with UK Good…
    • Join a major global finance transformation programme and lead the testing strategy for Oracle Fusion ERP and EPM implementation.*.
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    • Roles of this type typically sit within agile development teams delivering cloud-native and distributed systems across sectors such as financial services, life…
    • At least 3–5 years’ quality-management or senior quality-engineering experience within the medical-device industry.
    • Product quality and manufacturing support*.
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    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
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    • This contract role sits within our quality assurance function in Leeds, where QA engineers work closely with development, product and operations teams to…
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    • This SDET publication invites specialists to register interest in roles where test automation, microservices architecture and CI/CD pipeline work could converge…
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    • Quality Assurance Engineers play a vital role in ensuring software and systems meet rigorous quality standards before deployment.
  • View similar jobs with this employer
    • Quality assurance roles in testing and validation can be pivotal in ensuring that software and systems meet rigorous standards before they reach users.

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Medical Device Auditor
Scarlet
London
£75,000 - £90,000 a year
Full-time
Apply on company site

Job details

£75,000 - £90,000 a year
Full-time
London

Full job description

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 Medical Device Auditor at Scarlet based out of either our London or Sweden office, 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 — 40 minutes.

  • Culture and values interviews with James and Jamie — 30 minutes each.

  • References and offer.

Compensation Range: £75K - £90K

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