Software Quality Engineer, Cybersecurity Compliance
Core
Ensuring software quality and cybersecurity compliance for medical device products through risk management, documentation, and regulatory adherence.
Role type
Software Quality Engineer (Cybersecurity Compliance)
Builds
Medical device software products compliant with FDA and international standards
Domain
Healthcare / Medical Devices / Cybersecurity
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, Design controls (Class II), Automation frameworks, Agile SDLC, GMP, 21 CFR part 820, IEC 62304, ISO 14971, ISO 13485, CAPA management, Root-cause analysis, Test protocol review, Change management, Regulatory assessments
Preferred skills
Master's degree, ASQ CSQE, ISTQB, TestComplete, Coverity, C/C#/Java/Python, Clinical experience
Technologies
Jira, Jama, TestComplete, Coverity, Visual Studio
Responsibilities
Support Quality Engineering deliverables including risk management and cybersecurity risk activities; Guide development of SOPs, specifications, and test procedures; Review and document cybersecurity threat model outputs and vulnerability notifications; Manage CAPA including root-cause analysis and corrective actions; Coach team members on design quality and automated testing practices; Participate in system/software requirement and design reviews; Ensure DHF content integrity and regulatory compliance; Support internal and external audits; Perform external standard and regulation assessments.
Seniority
Mid-level IC