Quality Auditor

Cure Talent; Greater London; Remote; GBP 60,000 - 80,000; Full time

Benefits offered by this job

Remote working

Job summary

Cure Talent Limited is partnering with a growing medical device certification organisation specialising in SaMD and AI-enabled technologies. This UK-based role focuses on Stage 1 and Stage 2 ISO 13485 and EU MDR audits, with a few audit days per week plus reporting and follow-up.

Ideal candidates have hands-on SaMD QA experience, ISO 13485 knowledge, and a mindset geared to external auditing. Some travel to client sites and the London office may be required.

Qualifications

• Proven QA experience in medical devices.
• Hands-on SaMD experience incl software development, validation and QC.
• Deep knowledge of ISO 13485 and Medical Device QMS.
• Experience auditing in regulated medical device environments.
• Degree in science, engineering or related technical field.
• Knowledge of EU MDR, ISO 14971; familiarity with IEC 62304 and IEC 82304-1.

Responsibilities

• Conduct Stage 1 and Stage 2 audits against ISO 13485 and EU MDR.
• Plan and lead audit activities; review docs and interview stakeholders.
• Produce clear audit reports and communicate findings to manufacturers.
• Objectively assess nonconformities with evidence support.
• Collaborate with Quality, Regulatory, Software Eng and leadership teams.
• Manage audit activity end-to-end including prep, delivery, reporting and follow-up.

Skills

Quality Assurance

SaMD experience

Audit experience

Regulatory knowledge

Software development understanding

Communication skills

Judgement/assessment

Education

Science/Engineering degree

Job description

Cure Talent are delighted to be partnered with a growing medical device certification organisation specialising in Software as a Medical Device (SaMD) and AI-enabled medical technologies. With continued growth in demand, the business is expanding its UK audit team and looking to appoint further Medical Device Auditors.

This is an opportunity for an experienced medical device Quality professional with hands-on SaMD experience to move into external auditing. Prior experience working for a Notified Body is not essential. The business is particularly interested in candidates who understand what it is like to build, maintain and audit a compliant Quality Management System from within a medical device company and can bring that practical perspective into the audit environment.

The role is predominantly focused on conducting Stage 1 and Stage 2 ISO 13485 and EU MDR audits, typically involving three to four audit days per week alongside preparation, reporting and follow-up activities. The approach is evidence-led and collaborative rather than adversarial, with a strong emphasis on technical credibility, professional judgement and delivering a positive client experience without compromising regulatory standards.

Key Responsibilities

• Conduct Stage 1 and Stage 2 Quality Management System audits against ISO 13485 and applicable medical device regulatory requirements, particularly EU MDR.
• Plan and lead audit activity, reviewing documentation, interviewing relevant stakeholders and following evidence trails to assess conformity.
• Produce clear, technically robust audit reports and communicate findings effectively with manufacturers.
• Assess nonconformities objectively, ensuring conclusions are supported by appropriate evidence.
• Work closely with manufacturers across Quality, Regulatory, Software Engineering and senior leadership functions throughout the audit process.
• Manage audit activity independently, including preparation, delivery, reporting and follow-up within agreed timelines.

The Ideal Candidate Will Have

• Proven Quality Assurance experience within the Medical Device industry.
• Essential hands-on experience working with Software as a Medical Device (SaMD), including an understanding of software development, validation, testing and associated Quality controls.
• Extensive practical knowledge of ISO 13485 and Medical Device Quality Management Systems.
• Experience independently conducting internal, supplier or external audits within a regulated medical device environment.
• A relevant degree in science, engineering or another applicable technical discipline.
• Knowledge of medical device regulatory requirements, particularly EU MDR and ISO 14971, alongside familiarity with software standards such as IEC 62304 and IEC 82304-1.
• Strong communication skills, with the confidence to challenge appropriately while maintaining a professional, empathetic and collaborative approach.
• The ability to assess evidence objectively, apply sound judgement and recognise that different manufacturers may meet regulatory requirements in different ways.
• Genuine motivation to develop a career in external medical device auditing, working directly with different manufacturers and technologies.

This is a UK-based position offering remote working, with a preference for candidates based in or around London. Some travel to the London office and client sites will be required, with specific expectations discussed during the interview process.