Computer Software Assurance Engineer (CSA)

We (NavigaAI and US partner) are currently looking for a full-time, remote Computer Software Assurance (CSA) Engineer to ensure that our software applications for medical systems meet the highest quality, regulatory, and compliance standards. Core Requirements (Must-Haves) Proven expertise in software quality, non-product software validation (Tool Validation), and assurance principles for regulated or safety-critical environments. Professional working proficiency in English (spoken) for seamless cross-border collaboration. What You Will Do Implement risk-based CSA methodologies for our software development lifecycle and internal tooling (e.g., Jira, GitHub, Python, test automation tools). Assess software requirements, design robust yet lean test strategies, and execute "Fit for Purpose" validations. Document validation activities and risk assessments, ensuring full traceability of requirements to testing outcomes without creating unnecessary documentation overhead. Advise cross-functional stakeholders (product, engineering, and clinical teams) on software assurance best practices and CI/CD pipeline compliance (e.g., electronic signatures, audit trails). Support regulatory audits and inspections, continuously improving processes for documentation, defect tracking, and release readiness. What We Are Looking For Familiarity with relevant industry standards and regulations (e.g., FDA guidance on CSA, 21 CFR Part 11/820, GxP, ISO 13485, IEC 62304). Hands-on background in software QA or software engineering, including modern development practices like CI/CD, test automation, and version control. Solid understanding of databases, data integrity, and secure data lifecycle management. Strong cross-functional communication and project management skills. Bachelor’s degree in Computer Science, Engineering, Information Systems, or a related field. Ability to thrive in an independent, remote work environment across US time zones. To Apply: Please send your resume to info@navigaai.com