Remote Medical Device Lead Auditor

Creandum; United States; Teletrabalho; USD 110 000 - 165 000; Tempo parcial

Resumo da oferta

Scarlet is seeking a Freelance Medical Device Lead Auditor to independently deliver efficient, high-quality QMS audits for medical device manufacturers, in line with Scarlet’s standards and culture.

The role is part-time/contractor, fully remote with flexible scheduling depending on audit demand. Candidates must hold a Lead Auditor qualification and have experience with regulatory standards and notified bodies.

Qualificações

• Bachelor’s degree in one of the listed fields.
• Minimum 4 years of experience in the medical device industry.
• Minimum 2 years auditing or managing QMSs under ISO 13485, ISO 27001, ISO 42001, EU MDR or UK MDR.
• Prior work with notified bodies or accreditation bodies as a Lead Auditor.
• Knowledge of ISO 14971, IEC 62304, IEC 82304 and Cybersecurity.
• Ability to interpret and apply regulatory requirements reliably.

Responsabilidades

• Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, ISO 27001, ISO 42001, 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 methodology and values.

Conhecimentos

Auditing

QMS management

Regulatory interpretation

Formação académica

Bachelor’s degree in software engineering

Bachelor’s degree in computer science

Bachelor’s degree in physics or biophysics

Bachelor’s degree in biology or microbiology

Bachelor’s degree in chemistry or biochemistry

Bachelor’s degree in electrical, electronic, mechanical engineering or bioengineering

Bachelor’s degree in human physiology

Bachelor’s degree in medicine

Bachelor’s degree in pharmacy

Descrição da oferta de emprego

Scarlet is seeking a Freelance Medical Device Lead Auditor to independently deliver efficient, high-quality QMS audits for medical device manufacturers, in line with Scarlet’s standards and culture.

The role is part-time/contractor, fully remote with flexible scheduling depending on audit demand. Candidates must hold a Lead Auditor qualification and have experience with regulatory standards and notified bodies.