Remote Lead Auditor - Medical Device QMS (ISO 13485, MDR)

EF; Northern (KY); Hybrid; USD 90,000 - 150,000; Part time

Job summary

Scarlet is seeking a Lead Auditor Contractor to independently deliver efficient QMS audits for medical device manufacturers, operating fully remotely with flexible scheduling.

The role requires eligibility to be authorised as a Lead Auditor under ISO 13485, EU MDR, and UK MDR, with prior experience in audits and working with notified/accreditation bodies. Part-time/contractor status is offered.

Qualifications

• Bachelor’s degree in software engineering, computer science, physics/biophysics, biology/ microbiology, chemistry/ biochemistry, electrical/electronic/ mechanical engineering or bioengineering, human physiology, medicine or pharmacy.
• Minimum 4 years of experience in the medical device industry.
• Minimum 2 years 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.
• Knowledge of ISO 14971, IEC 62304, IEC 82304, Cybersecurity.

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.

Skills

Auditing

QMS audits

Regulatory compliance

Documentation

Independent work

Regulatory requirements

Education

software engineering

computer science

physics or biophysics

biology or microbiology

chemistry or biochemistry

electrical, electronic, mechanical engineering or bioengineering

human physiology

medicine

pharmacy

Job description

Scarlet is seeking a Lead Auditor Contractor to independently deliver efficient QMS audits for medical device manufacturers, operating fully remotely with flexible scheduling.

The role requires eligibility to be authorised as a Lead Auditor under ISO 13485, EU MDR, and UK MDR, with prior experience in audits and working with notified/accreditation bodies. Part-time/contractor status is offered.