Software Quality Engineer
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-10-12
Listing for:
Real Staffing Group
Full Time
position Listed on 2026-10-12
Job specializations:
-
Software Development
Software Testing, Software Project Mgr/ Lead, Software Architect, DevOps
Job Description & How to Apply Below
Key responsibilities
Software life cycle quality
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
Risk management
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
Verification and validation
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)
Cybersecurity Partner with engineering on medical device cybersecurity, including threat modeling, SBOM management, vulnerability monitoring and FDA premarket cybersecurity documentation (IEC 81001-5-1, AAMI TIR
57)
Regulatory and compliance
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
Post-market and continuous improvement
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)
Leadership 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
Required qualifications
Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering or a related technical field
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
Preferred qualifications
Master's degree in a technical field and 5 years medical device experience;
Experience with IVD instruments, assay analysis software or life science tools (e.g., proteomics, genomics, lab automation)
EU IVDR/MDR technical documentation and notified body experience
Medical device cybersecurity experience (FDA premarket guidance, IEC 81001-5-1, SBOM, threat modeling)
Experience with Software as a Medical Device (SaMD), cloud-hosted software or AI/ML-enabled device software
Familiarity with Agile in regulated settings (AAMI TIR
45) and tools such as Jira, Jama/Polarion, Git and CI/CD pipelines
Test automation background (e.g., Python, pytest, Robot Framework)
Certifications such as ASQ CSQE, CQE or CQA, or ISO 13485 Lead AuditorEOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law.
Eligibility may vary based on factors such as location and hire date and is subject to change.
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