Full-Time Senior Quality Engineer - AI

SWORD Health is seeking a highly motivated and experienced Senior Quality Engineer specializing in AI/ML to join our growing Quality and Regulatory Affairs team.

This fully remote role (Portugal residents only) offers the opportunity to play a critical role in ensuring the safety and effectiveness of our cutting-edge AI-powered SaMD products.

Responsibilities:

• Quality Assurance for AI/ML-enabled SaMD: Develop, implement, and maintain the quality management system, ensuring compliance with internal QMS procedures and external regulations (FDA, EU AI Act, Health Canada, etc.).
• Regulatory compliance for AI/ML: Interpret and implement relevant regulatory guidance to ensure AI/ML software meets all applicable requirements for safety, performance, and cybersecurity.
• Risk management: Lead AI-specific risk assessments, including bias, algorithmic drift, and security vulnerabilities.
• Verification and Validation: Plan, coordinate, and execute AI/ML software verification and validation activities. Develop robust testing strategies to evaluate model accuracy, robustness, and performance.
• Documentation and Process Development: Create, update, and maintain comprehensive documentation related to AI/ML development, risk management, V&V, and regulatory compliance.
• Training and Communication: Provide training to internal teams on AI/ML-specific quality and regulatory requirements.
• Continuous Improvement: Lead continuous improvement initiatives to enhance AI/ML development and quality processes.

Qualifications:

• Bachelor's degree in Computer Science, Engineering, or related field.
• 4+ years of experience in Quality Software Engineering or a related role within the medical device industry.
• Proven experience with AI/ML-enabled SaMD development and quality assurance.
• Strong understanding of AI/ML lifecycle processes, including data management, algorithm training, model validation, CI/CD pipeline, DevOps, and Predetermined Change Control Plan (PCCP).
• Hands-on experience with regulatory requirements for AI/ML-enabled medical devices (FDA, EU AI Act, Health Canada).
• Proficiency in risk management methodologies, including FMEA for AI/ML systems.
• Project & Process Management skills
• Excellent documentation skills and attention to detail.
• Familiarity with software tools like Jira, Confluence, and version control systems.
• Strong analytical and problem-solving skills.
• Effective communication and collaboration abilities.
• Fluent in English.

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