Staff Cloud Software Quality & Compliance Engineer
Core
Strengthen software quality practices and ensure audit readiness for digital, connected, SaaS, and cloud-based products by guiding teams through Quality Management System processes and translating regulatory requirements into scalable development processes.
Role type
Staff Software Quality Assurance Engineer (Quality Systems & Compliance)
Builds
Production software quality systems, SDLC governance frameworks, and audit-ready compliance evidence for medical device and healthcare technology products.
Domain
Medical devices / Digital Health / Healthcare Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software Quality Management Systems (QMS), SDLC governance, risk management, audit readiness, process improvement, regulatory translation, cross-functional influence, Agile/DevOps/CI/CD knowledge, gap assessment, root-cause analysis, corrective and preventive actions (CAPA)
Preferred skills
Advanced technical degree, prior software engineering experience, regulated industry experience (medical devices/digital health), specific framework knowledge (SOC 2, ISO 27001, HIPAA, FDA, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485), cloud platform knowledge, professional quality certifications (CSQE, CQE, CQA)
Technologies
SOC 2, ISO 27001, HIPAA, FDA, 21 CFR Part 11, IEC 62304, ISO 14971, ISO 13485, Cloud platforms, DevOps, CI/CD
Responsibilities
Guide software teams through QMS processes and documentation requirements; Develop and improve software quality procedures, work instructions, and templates; Support internal and external audits through gap assessments, evidence collection, and remediation; Partner with cross-functional teams to translate regulatory requirements into practical development processes; Identify process gaps and support improvements for consistency and efficiency; Participate in design reviews, risk assessments, and release-readiness activities
Seniority
Staff, hands-on IC with strategic influence
