Senior Remote Auditor — Medical Device QMS

Scarlet; United States; À distance; USD 83 000 - 165 000; Temps partiel

Résumé du poste

Scarlet is seeking a Lead Auditor - Contractor to independently deliver efficient QMS audits for medical device companies, ensuring compliance with ISO 13485, EU MDR and UK MDR. This fully remote, part-time role fits auditors who can work flexible schedules based on audit demand.

You’ll work within Scarlet’s notified body activities, delivering audits with minimal supervision and applying the company’s standards and tooling to ensure consistent quality.

Qualifications

• Bachelor’s degree in a relevant field (see list)
• Minimum 4 years in medical device industry
• Minimum 2 years auditing QMSs under ISO 13485 / EU MODR
• Experience with notified bodies or accreditation bodies as Lead Auditor
• Knowledge of ISO 14971, IEC 62304, IEC 82304, Cybersecurity

Responsabilités

• Conduct remote QMS audits under ISO 13485, EU MDR, UK MDR
• Provide clear, structured audit documentation and conclusions
• Ensure high-quality audits aligned with Scarlet’s methodology and values

Connaissances

QMS audits

Regulatory interpretation

Auditing

Formation

Bachelor's degree fields (one of listed)

Description du poste

Scarlet is seeking a Lead Auditor - Contractor to independently deliver efficient QMS audits for medical device companies, ensuring compliance with ISO 13485, EU MDR and UK MDR. This fully remote, part-time role fits auditors who can work flexible schedules based on audit demand.

You’ll work within Scarlet’s notified body activities, delivering audits with minimal supervision and applying the company’s standards and tooling to ensure consistent quality.