Lead Auditor – Contractor Role

Job not on LinkedIn

🕒 January 8

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🔎 Auditor

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Scarlet

WebsiteLinkedInAll Job Openings

1 - 10 employees

📚 Education

👥 HR Tech

⚡ Productivity

Education • HR Tech • Productivity

Scarlet is a company dedicated to leadership development across various stages of life. It offers customized courses and tips for both in-person and virtual formats to help leaders elevate their skills and make a real impact. Scarlet provides training in areas such as intern etiquette, business networking, presentation skills, and socializing effectively in business environments. The company emphasizes personal growth, authentic communication, and unlocking leadership potential. Scarlet aims to support individuals in navigating life and leadership with confidence and skill.

📋 Description

• 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