Lead Auditor - Contractor role

About the role

We are expanding our auditor pool and are looking for part-time/contractor lead auditors who can independently deliver audits in line with Scarlet’s standards, approach, and culture.

Responsibilities

• Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
• Provide clear, structured audit documentation and evidence-based conclusions.
• Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.

Requirements

• Education: Bachelor’s degree in: software engineering, computer science, physics or biophysics, biology or microbiology, chemistry or biochemistry, electrical, electronic, mechanical engineering or bioengineering, human physiology, medicine, pharmacy.
• Professional experience: Minimum 4 years of experience in the medical device industry, minimum 2 years of experience auditing or managing QMSs under: ISO 13485, EU MDR and/or UK MDR.
• Prior work with notified bodies or accreditation bodies as a Lead Auditor.
• Practical experience working with software.
• Auditing experience.
• Technical experience.
• Experience with software medical devices (SaMD) is strongly preferred.
• Working knowledge of relevant standards, such as: ISO 14971, IEC 62304, IEC 82304, Cybersecurity.

Qualifications

• Strong regulatory judgement — confident in interpreting and applying regulatory requirements.
• Consistency & quality focus — cares deeply about audit quality and repeatability.
• Clear communicator — explains findings and requirements clearly and constructively.
• Independent & reliable — delivers audits with minimal oversight.
• Aligned mindset — open to adopting Scarlet’s values, audit methods and tooling.