Senior Software Quality Engineer - Med Device Compliance

Real Staffing Group; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Real Staffing Group seeks an experienced Software Quality Leader for medical device software in the San Francisco area. You will own the software lifecycle quality per IEC 62304 and lead risk management across ISO 14971, with a focus on ensuring audit-ready DHF content and regulatory compliance.

You will collaborate with engineering to drive verification, validation, cybersecurity and regulatory submissions (510(k)/PMA/De Novo) while mentoring teams on quality processes and risk-based decision

Qualifications

• Bachelor's degree in a technical field required.
• 10+ years in software quality, software engineering or software V&V, with at least 6 years in a regulated medical device or IVD environment.
• Deep working knowledge of IEC 62304, ISO 14971, ISO 13485 and 21 CFR 820 (QMSR).
• Hands‑on experience authoring or approving software DHF content for FDA submissions (510(k), De Novo or PMA).
• Experience with software validation (CSV/CSA) and 21 CFR Part 11 / data integrity.
• Proven record leading CAPAs, root cause investigations and audit responses.
• Solid technical fluency: able to read code, review architecture and challenge test strategy credibly with engineers.
• Clear writer and communicator who can influence without authority across functions.

Responsibilities

• Own quality oversight of the software development lifecycle per IEC 62304, including software safety classification, development planning, requirements, architecture, verification and release
• Review and approve software plans, requirements, design documents, traceability matrices, test protocols and reports, and anomaly lists
• Define and continuously improve software quality procedures and work instructions within the QMS, keeping them practical for Agile and CI/CD teams
• Ensure complete, audit-ready design history file (DHF) content for software
• Lead software risk analysis per ISO 14971 IEC 62304, including software hazard analysis, failure modes and SOUP/OTS risk assessment
• Ensure risk controls implemented in software are traced to requirements and verified
• Guide verification strategy across unit, integration and system levels, including test automation and coverage expectations
• Drive validation of software used in production, the QMS and data integrity (CSV/CSA, 21 CFR Part 11)
• Partner with engineering on medical device cybersecurity, including threat modeling, SBOM management, vulnerability monitoring and FDA premarket cybersecurity documentation (IEC 81001-5-1, AAMI TIR57)
• Prepare software documentation for 510(k), De Novo, PMA and EU IVDR/MDR submissions; respond to agency questions
• Represent software quality in FDA inspections, notified body audits and internal audits
• Keep the organization current on evolving standards and guidance, including the FDA QMSR (ISO 13485 alignment) and AI/ML-enabled device software guidance
• Lead software-related CAPAs, nonconformances, complaint investigations and root cause analysis
• Assess software changes for regulatory impact and manage field updates and patches
• Define and report software quality metrics (escaped defects, CAPA cycle time, audit findings)
• Mentor quality and software engineers; train teams on 62304, 14971 and good documentation practice
• Act as a trusted advisor to engineering leadership on quality strategy and risk-based tradeoffs

Education

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

Job description

Real Staffing Group seeks an experienced Software Quality Leader for medical device software in the San Francisco area. You will own the software lifecycle quality per IEC 62304 and lead risk management across ISO 14971, with a focus on ensuring audit-ready DHF content and regulatory compliance.

You will collaborate with engineering to drive verification, validation, cybersecurity and regulatory submissions (510(k)/PMA/De Novo) while mentoring teams on quality processes and risk-based decision