Senior Cybersecurity Quality Engineer, SaMD

Verily Health; San Bruno (CA); On-site; USD 113,000 - 170,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Verily Health in the United States seeks a Senior Quality Engineer, Cybersecurity, a hands-on, IC role bridging quality engineering and cybersecurity across SaMD and consumer products. You will embed cybersecurity into the QMS, align with FDA QMSR, ISO 13485, and SDLC processes, identify risks, and drive cross-functional initiatives.

Responsibilities include leading QMS improvements, guiding DDFs and risk management, overseeing post-market surveillance, CAPA and audits, and partnering with

Qualifications

• 5+ years in software quality engineering in FDA QMSR / ISO 13485 medical device industry (SaMD).
• Proven expertise in medical device cybersecurity and related standards (FDA guidance, AAMI TIR57).
• Experience applying IEC 62304, ISO 14971, IEC 62366 in regulated environments.
• Experience with Google Workspace, Jira, GitHub, and document control systems.

Responsibilities

• Lead ongoing implementation and continuous improvement of the Software Quality Management System (QMS) across consumer, research, and SaMD product domains — in conformance with FDA QMSR, ISO 13485:2016 design controls, and SDLC processes — integrating internal best practices and medical device industry standards.
• Guides software development teams in the creation and maintenance of Design and Development Files (DDFs), including software development plans, verification and validation plans, software requirements specifications, architecture and design documents, design and code reviews, Risk Management Files (RMF), test protocols and reports, and traceability matrices.
• Supports integration of ISO 14971 risk management, IEC 62366 usability engineering, and FDA cybersecurity guidance into SDLC processes, ensuring a cohesive and compliant approach to product safety, security, and usability across the development lifecycle.
• Supports post-market cybersecurity surveillance activities for SaMD and LLM-enabled products, including monitoring for emerging threats, coordinating vulnerability disclosures, and assessing the impact of security findings on regulated product safety and performance.
• Provides CAPA, complaints, audit, and QMS support related to software and cybersecurity incidents, driving root cause analysis and effective corrective actions across product teams.

Skills

Cybersecurity

QMS

SDLC

Regulatory compliance

Education

Bachelor's degree in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or related field

5+ years in software quality engineering in FDA QMSR / ISO 13485 medical device industry

Tools

Google Workspace

Jira

GitHub

Job description

Verily Health in the United States seeks a Senior Quality Engineer, Cybersecurity, a hands-on, IC role bridging quality engineering and cybersecurity across SaMD and consumer products. You will embed cybersecurity into the QMS, align with FDA QMSR, ISO 13485, and SDLC processes, identify risks, and drive cross-functional initiatives.

Responsibilities include leading QMS improvements, guiding DDFs and risk management, overseeing post-market surveillance, CAPA and audits, and partnering with