Quality Auditor

Cure Talent; Stockholms kommun; Remote; SEK 900,000 - 1,100,000; Full time

Job summary

Cure Talent Limited is partnering with a growing medical device certification organisation specialising in SaMD and AI-enabled medical technologies. We seek an experienced Medical Device Auditor to conduct Stage 1 and Stage 2 ISO 13485 and EU MDR audits from a Sweden-based, remote setup with travel to Stockholm and client sites as needed.

The ideal candidate has hands-on SaMD experience, strong ISO 13485 knowledge and a track record auditing in regulated environments.

Qualifications

• Hands-on SaMD experience and regulatory understanding.
• Practical knowledge of ISO 13485 quality management systems.
• Familiarity with EU MDR and related software standards.

Responsibilities

• Conduct Stage 1 and Stage 2 ISO 13485 and EU MDR audits.
• Plan, lead and document audit activities with evidence trails.
• Produce robust audit reports and communicate findings clearly.
• Assess nonconformities with objective evidence.
• Collaborate with Quality, Regulatory, Software Engineering and leadership.
• Manage audit timelines from preparation to follow-up.

Skills

SaMD experience

ISO 13485 knowledge

MDR / EU regulatory knowledge

Auditing experience

Strong communication

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