Senior Software QA Engineer I
Core
Ensures software quality, safety, and regulatory compliance for medical devices, manufacturing systems, and digital platforms.
Role type
Senior Software QA Engineer (Regulated Medical Devices)
Builds
Software quality plans, risk analyses, compliance reports, and validated software for medical devices.
Domain
Medical Devices / Software Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software assurance, risk analysis (FMEA, hazard analysis, fault-tree), regulatory compliance (21 CFR 820.30, ISO 13485, IEC 62304, ISO 14971), supplier evaluation, change management, vulnerability management, requirements review, code structure interpretation
Preferred skills
Class II/III medical device experience, AI/ML in regulated environments, cyber-security standards (UL 2900), quality certifications (ASQ CSQE, ISTQB, CQE), manufacturing software validation
Technologies
Jira, Monday.com
Responsibilities
Develop and maintain software quality plans aligned with design controls; lead software risk analysis and CSA risk activities; review and approve protocols, traceability matrices, and reports; evaluate and qualify software suppliers; lead investigations for software-related issues; ensure robust change management and regression strategies; partner on vulnerability management and secure design.
Seniority
Senior, hands-on IC
