Senior Quality Engineer - Cybersecurity for SaMD

Verily Health; Dallas (TX); On-site; USD 113,000 - 170,000; Full time

Job summary

Verily Health in the United States is seeking a Senior Quality Engineer, Cybersecurity to lead quality and security across the consumer, research, and SaMD product portfolio, aligning with FDA QMSR and ISO 13485 in the SDLC.

This hands-on role drives risk management, threat modeling, vulnerability management, and secure coding, collaborating with engineering, security, and product teams to embed cybersecurity requirements into design and verification.

Qualifications

• Bachelor's degree or equivalent with 5+ years in software quality engineering in FDA QMSR / ISO 13485 SaMD.
• Proven expertise in medical device cybersecurity and FDA guidance (AAMI TIR57).
• Experience applying IEC 62304, ISO 14971, IEC 62366 in a regulated development environment.
• Collaboration with software development and security teams using Jira/GitHub workflows.

Responsibilities

• Lead ongoing implementation and improvement of the Software QMS across SaMD domains per FDA QMSR/ISO 13485.
• Embed security requirements, threat modeling, vulnerability management in SDLC and QMS.
• Guide design documents, risk management files, test protocols, and traceability matrices.
• Support post-market cybersecurity surveillance, CAPA, and audit activities.

Skills

Quality engineering

Cybersecurity

QMS Regulation

SDLC

Risk Management

Regulatory Standards

collaboration

FDA Guidance

Education

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

Tools

Jira

GitHub

Google Workspace

Document Control

Job description

Verily Health in the United States is seeking a Senior Quality Engineer, Cybersecurity to lead quality and security across the consumer, research, and SaMD product portfolio, aligning with FDA QMSR and ISO 13485 in the SDLC.

This hands-on role drives risk management, threat modeling, vulnerability management, and secure coding, collaborating with engineering, security, and product teams to embed cybersecurity requirements into design and verification.