A detail-oriented Expert Quality Engineer focused on software and AI, responsible for ensuring the quality and regulatory compliance of AI-powered medical devices across various platforms, collaborating with cross-functional teams to uphold safety and effectiveness standards.
Key Responsibilities
Ensure the quality and regulatory compliance of AI-powered SaMD products.
Collaborate with cross-functional teams including software development, regulatory affairs, and quality assurance.
Apply quality assurance skills across various deployment platforms such as mobile applications, cloud services, edge devices, and AI platforms.
Maintain safety and effectiveness standards for products across different therapeutic areas.
Requirements
Possess a strong understanding of software quality assurance principles and practices, with a focus on AI-powered SaMD products.
Experience collaborating with cross-functional teams including software development, regulatory affairs, and quality assurance to ensure product safety and effectiveness.
Ability to ensure regulatory compliance of AI-powered SaMD products according to applicable standards and regulations.
Proficiency in applying quality engineering skills across multiple deployment platforms such as mobile applications, cloud services, edge devices, and AI platforms.
Detail-oriented with a strong focus on maintaining high standards of safety, quality, and regulatory compliance in software products.
Legal right to work in the United States or possession of a valid EU visa and be based in Portugal, as applicable (candidates in Portugal must have a valid EU visa; US candidates must have legal work authorization in the US).
Full-time employment status with the ability to work regularly 25 hours per week or more.
Ability to work remotely, with flexibility in working hours, and to operate independently in a remote work environment.