About the role

As a Lead Auditor Contractor at Scarlet, you will independently deliver efficient, high-quality QMS audits that help innovative medical device companies meet the highest regulatory standards.

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

This role is suited for auditors who fulfil the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR and UK MDR. You will work flexibly, supporting audit delivery as part of Scarlet’s notified body activities. This is a fully remote role, with flexible scheduling, subject to audit demand and availability.

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.

Required qualifications

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
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
Working knowledge of relevant standards, such as:
- ISO 14971
- IEC 62304
- IEC 82304
- Cybersecurity
Evidence of confidently interpreting and applying regulatory requirements.
Evidence of delivering consistent, high-quality audits.
Ability to explain findings and requirements clearly and constructively.
Ability to deliver audits independently with minimal oversight.
Willingness to adopt Scarlet’s values, audit methods and tooling.

Preferred qualifications

Responsibilities

About the role

As a Lead Auditor Contractor at Scarlet, you will independently deliver efficient, high-quality QMS audits that help innovative medical device companies meet the highest regulatory standards.

We’re expanding our auditor pool and we're 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.

Required qualifications

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
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
Working knowledge of relevant standards, such as:
- ISO 14971
- IEC 62304
- IEC 82304
- Cybersecurity
Evidence of confidently interpreting and applying regulatory requirements.
Evidence of delivering consistent, high-quality audits.
Ability to explain findings and requirements clearly and constructively.
Ability to deliver audits independently with minimal oversight.
Willingness to adopt Scarlet’s values, audit methods and tooling.