Senior Quality Engineer, Cybersecurity for SaMD & AI Health

Verily Health; Boston (MA); On-site; USD 113,000 - 170,000; Full time

Job summary

Verily Health is seeking a Senior Quality Engineer, Cybersecurity to bridge quality engineering and cybersecurity across its SaMD portfolio. You will ensure QMS alignment with FDA QMSR, ISO 13485, and SDLC standards while partnering with engineering, security, and product teams to embed cybersecurity in development lifecycles.

Responsibilities include risk management, incident CAPA, and post-market surveillance, with a focus on delivering reliable, compliant, and secure software products for

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, or related field; 5+ years in software quality engineering within the FDA QMSR / ISO 13485 medical device industry, focusing on SaMD.
• Experience applying IEC 62304, ISO 14971, IEC 62366, and AAMI TIR57 in regulated software environments.
• Strong collaboration with software development and security teams; proficiency with tooling to operationalize quality and cybersecurity requirements.

Responsibilities

• Leads ongoing implementation and improvement of the Software Quality Management System (QMS) across product domains in FDA QMSR and ISO 13485 contexts.
• Serves as Quality Lead for cybersecurity, embedding security requirements and threat modeling into SDLC/QMS per FDA guidance.
• Guides creation and maintenance of Design & Development Files, RMF, test protocols, and traceability matrices.
• Supports ISO 14971 risk management and usability engineering within SDLC processes.
• Assists post-market cybersecurity surveillance and vulnerability coordination.

Skills

Software quality engineering

Cybersecurity

Regulatory compliance

Cross-functional leadership

Education

Bachelor's degree in Computer Science or related field

Tools

Google Workspace

Jira

GitHub

Document control systems

Job description

Verily Health is seeking a Senior Quality Engineer, Cybersecurity to bridge quality engineering and cybersecurity across its SaMD portfolio. You will ensure QMS alignment with FDA QMSR, ISO 13485, and SDLC standards while partnering with engineering, security, and product teams to embed cybersecurity in development lifecycles.

Responsibilities include risk management, incident CAPA, and post-market surveillance, with a focus on delivering reliable, compliant, and secure software products for