Medical Device Quality Engineer
Scarlet(5 days ago)
About this role
Scarlet is a leader in the regulation and certification of AI medical devices, focusing on ensuring compliance with international quality standards. The role involves working with innovative healthcare companies to interpret regulatory requirements, optimize audit processes, and maintain approvals across jurisdictions. Join a team dedicated to advancing healthcare technology through operational excellence and regulatory expertise.
Required Skills
- ISO 13485
- ISO 9001
- EU MDR
- ISO 27001
- IEC 62304
- IEC 82304
- Regulatory Affairs
- Quality Management
- Auditing
- Cyber Security
Qualifications
- Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent
- Minimum four years of professional experience in medical devices
- Minimum two years of experience in quality management
- Experience auditing against medical device quality requirements
About Scarlet
www.scarlet.ccScarlet 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.
View more jobs at Scarlet →