Scarlet

Lead Auditor – Contractor Role

Scarlet

contract

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Cyber Security

About the role

  • 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

  • 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
  • Preferred: Practical experience working with software.
  • Prior work with notified bodies or accreditation bodies as a Lead Auditor
  • Experience with software medical devices (SaMD) is strongly preferred
  • Working knowledge of relevant standards, such as:
  • - ISO 14971
  • - IEC 62304
  • - IEC 82304
  • - Cybersecurity
Benefits
  • Fully remote
  • Flexible scheduling, subject to audit demand and availability

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
ISO 13485EU MDRUK MDRISO 14971IEC 62304IEC 82304CybersecurityQuality Management Systemsauditingsoftware medical devices
Soft skills
clear communicationstructured documentationevidence-based conclusionshigh-quality audit experiencesalignment with methodology and values