About the job
At Scarlet, we are on a mission to accelerate the shift towards universally accessible healthcare solutions. We hold governmental authority to evaluate and endorse market entry for medical AI technologies. Our innovative methodology facilitates the swift and safe delivery of cutting-edge technology to patients in need.
As a leader in the field of AI medical devices, Scarlet collaborates with significant players in the healthcare sector. We take pride in partnering with some of the world's most resourceful and ambitious companies that are revolutionizing medical AI. By joining our team, you will contribute to a thriving organization with a proven product-market fit, abundant data flow, and rapidly increasing revenue.
Join us in our commitment to provide the next generation of healthcare to those who require it most.
About this Position:
The Quality Team at Scarlet plays a crucial role in guiding Medical Device Manufacturers to meet and surpass the Quality Management System (QMS) standards set by regulatory bodies. With extensive knowledge of regulatory requirements, our team crafts streamlined workflows to facilitate timely and secure QMS audits for the latest Healthtech innovations.
The primary objective of the Quality Team is to ensure thorough compliance and operational excellence, both within Scarlet and for the Medical Device Manufacturers we support.
Your Key Responsibilities:
Gain authorization to audit and certify the quality management systems of the most pioneering healthcare companies worldwide.
Analyze, interpret, and implement relevant quality standards (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.).
Enhance customer data assessments by developing efficient audit processes.
Participate in the maintenance and expansion of Scarlet’s approvals across different jurisdictions and technologies.
Essential Skills:
Education: Bachelor's degree in engineering, software engineering, computer science, physics, or a related field.
Experience: A minimum of four years in the medical device industry.
Experience: At least two years of experience in quality management (e.g., ISO 13485, EU MDR, ISO 14971, etc.).
Experience: Proven experience in auditing medical device quality management requirements (e.g., ISO 13485, EU MDR, ISO 14971, etc.).
Technical Skills: At least one year of hands-on experience working with medical device quality management systems.
