Senior Medical Device Software Quality Lead

Real; San Francisco (CA); On-site; USD 140,000 - 230,000; Full time

Job summary

Real is seeking a senior software quality leader to own the lifecycle of medical device software in a regulated setting. You will collaborate with engineering on IEC 62304, ISO 14971 and 21 CFR 820, drive risk management, and ensure audit-ready documentation and DHF completeness.

You will mentor teams, guide cybersecurity and regulatory submissions, and report quality metrics for continuous improvement across post-market activities.

Qualifications

• 8+ years in software quality, development or V&V in regulated medical devices or IVD.
• Deep knowledge of IEC 62304, ISO 14971, ISO 13485 and 21 CFR 820 (QMSR).
• Experience authoring or approving FDA submissions (510(k), De Novo or PMA).
• Experience with CSV/CSA and data integrity; CAPA and audit responses.
• Strong cross-functional leadership in regulated environments.

Responsibilities

• Own software quality oversight of the SDLC per IEC 62304 and arch/requirements verification.
• Review and approve plans, design docs, traceability matrices, test reports and DHF.
• Lead risk management and assurance activities; ensure risk controls traced to requirements.
• Oversee software cybersecurity collaboration, threat modeling and SBOM management.
• Prepare regulatory documentation and represent software quality in inspections/audits.
• Lead post-market actions, CAPAs, field updates and metrics reporting.
• Mentor engineers and align quality strategy with engineering leadership.

Skills

Quality assurance

Regulatory compliance

Leadership

Cross-functional teamwork

Education

Bachelor's in engineering or related field

Master's degree (preferred)

Tools

Jira

Git

CI/CD pipelines

Jama/Polarion

Job description

Real is seeking a senior software quality leader to own the lifecycle of medical device software in a regulated setting. You will collaborate with engineering on IEC 62304, ISO 14971 and 21 CFR 820, drive risk management, and ensure audit-ready documentation and DHF completeness.

You will mentor teams, guide cybersecurity and regulatory submissions, and report quality metrics for continuous improvement across post-market activities.