Principal Software Quality Engineer

$109,000 – $185,000 · Posted 3 days ago

NorthridgeLast seen 1 day ago

Summary

Principal Software Quality Engineer leading quality strategy and oversight for digital health solutions including mobile apps (iOS/Android), web applications, cloud services (AWS/IBM Watson), and AI/ML solutions in a regulated medical device environment. Responsibilities include driving quality into design and development across SDLC phases (Waterfall/Agile/DevOps), leading design reviews, conducting risk management and FMEAs, managing defects, developing quality standards and procedures, leading CAPA initiatives, and supporting regulatory compliance and audits. Requires 7+ years in quality/engineering/software development with deep knowledge of medical device compliance standards (ISO 13485, IEC 62304, HIPAA, FDA QMSR). Experience with mobile/web development, cloud infrastructure, ALM tools, and defect tracking is preferred.

DevOps / Infrastructure Quality Assurance AWS Azure Agile AI Alm Tools Android Atlassian Suite Bluetooth Capa Cqe Csqe Defect Tracking Design Reviews DevOps Fda Qmsr Fmea Hipaa Ibm Watson Iec 62304 iOS Iso 13485 Jira Machine Learning Ptc Integrity Risk Management Sdlc Tfs Verification And Validation Waterfall