Lead Auditor - Contractor role

Scarlet

2 months ago

3.6 on Glassdoor

Remote

Full Time

Senior

2 applicants

View Job Listing

Apply to 100+ jobs

About this role

The Lead Auditor at Scarlet is responsible for conducting remote audits of medical device manufacturers' Quality Management Systems in compliance with ISO 13485, EU MDR, and UK MDR standards. This part-time contractor role requires the auditor to provide structured documentation and evidence-based conclusions while ensuring a consistent and high-quality audit experience aligned with Scarlet's methodologies. Candidates must have a relevant educational background, substantial medical device industry experience, and prior auditing work with notified bodies.

Skills

Qualifications

Bachelor’s degree in software engineeringBachelor’s degree in computer scienceBachelor’s degree in physics or biophysicsBachelor’s degree in biology or microbiologyBachelor’s degree in chemistry or biochemistry

About Scarlet

www.scarlet.cc

Scarlet is Europe's only Notified Body specializing in the certification of software and AI as medical devices. The company streamlines the certification process for Software as a Medical Device (SaMD) and AI-based Medical Devices (AIaMD), helping manufacturers bring their innovative solutions to market efficiently. Scarlet's mission is to facilitate the transition to universally accessible healthcare by enabling their clients to meet regulatory standards without unnecessary delays. By focusing on specialized processes for software and AI technology, Scarlet aims to enhance the overall quality and availability of healthcare solutions.