Cybersecurity Quality Engineer, SaMD Leader

Verily Life Sciences LLC; Texas; Hybride; USD 113 000 - 170 000; Plein temps

Résumé du poste

Verily Health is seeking a Senior Quality Engineer, Cybersecurity to bridge quality engineering and cybersecurity across the SaMD and broader product portfolio. This hands-on role leads QMS improvements, embeds security into the SDLC, and partners with engineering, security, and product teams to meet FDA QMSR and ISO 13485 standards.

You will drive risk assessment, design and code reviews, and post-market surveillance for SaMD and AI-enabled products, ensuring regulatory compliance, robust

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, or a related field with 5+ years in software quality engineering in FDA QMSR/ISO 13485 medical devices.
• Proven expertise in medical device cybersecurity and FDA guidance with applicable standards (AAMI TIR57).
• Experience applying IEC 62304, ISO 14971, IEC 62366 within a regulated software development environment.

Responsabilités

• Leads ongoing implementation and continuous improvement of the QMS across SaMD domains per FDA QMSR and ISO 13485.
• Embeds security requirements, threat modeling, vulnerability management into SDLC and QMS per FDA cybersecurity guidance.
• Guides teams in DDFs, verification/validation plans, RMF, and traceability matrices.
• Supports post-market cybersecurity surveillance and CAPA for software and SaMD products.

Connaissances

Quality engineering

Cybersecurity

Regulatory compliance

Cross-functional collaboration

Risk management

Formation

Bachelor's degree in CS/SE or related

Outils

Jira

GitHub

Google Workspace

Description du poste

Verily Health is seeking a Senior Quality Engineer, Cybersecurity to bridge quality engineering and cybersecurity across the SaMD and broader product portfolio. This hands-on role leads QMS improvements, embeds security into the SDLC, and partners with engineering, security, and product teams to meet FDA QMSR and ISO 13485 standards.

You will drive risk assessment, design and code reviews, and post-market surveillance for SaMD and AI-enabled products, ensuring regulatory compliance, robust