Role Summary:We are looking for an experienced Software Quality Engineer (SQE) to drive Software Verification & Validation (V&V;) activities for cloud services, edge applications, and platform solutions in a regulated medical-device software environment.The role will focus on test planning, test automation, API and web testing, requirements traceability, defect management, release verification, and maintaining audit-ready quality documentation.Key Responsibilities:- Develop test strategies, test plans, test cases, and verification protocols.- Perform manual, exploratory, integration, system, regression, and end-to-end testing.- Review requirements, architecture, and user stories for completeness and testability.- Develop and maintain automated tests for APIs, backend services, web applications, system and command-line tools.- Develop automation using C#/.NET or TypeScript/JavaScript.- Work with Playwright, Cypress, or Selenium for web automation.- Integrate automated tests into CI/CD pipelines.- Analyze test failures and improve test coverage and automation reliability.- Manage end-to-end requirements traceability using Jama Connect.- Maintain traceability between Requirements, Risk Controls, Test Cases, Test Results, and Defects.- Prepare traceability matrices, coverage reports, test evidence, verification reports, and quality summaries.- Log, track, verify, and retest defects using Jira/Azure DevOps.- Perform regression impact analysis and root-cause investigations.- Support Test Readiness Reviews (TRR), release reviews, and phase-gate assessments.- Ensure audit-ready test documentation and approvals.- Collaborate with Development, Product, Architecture, Quality,



and Regulatory teams in an Agile/Scrum environment.Mandatory Skills:- 6+ years of Software Testing / Software Quality Engineering experience.- Strong experience in Software Verification & Validation (V&V;).- Hands-on Test Automation experience.- Strong programming experience in C#/.NET OR TypeScript/JavaScript.- Hands-on experience with Playwright, Cypress, or Selenium.- Strong API / REST API testing experience.- Experience in manual, integration, system, regression, and E2E testing.- Strong understanding of SDLC/STLC.- Experience with CI/CD and Git.- Experience with Jira or Azure DevOps.- Experience working in Agile/Scrum.- Strong understanding of defect management and test documentation.Medical / Regulatory Experience Mandatory Priority:- Experience testing Medical Device Software / Healthcare Software.- Knowledge or hands-on experience with IEC 62304.- Knowledge of ISO 13485.- Knowledge of ISO 14971 / Risk Management.- Understanding of FDA/MDR software guidance.- Experience with requirements traceability and risk-based testing.- Experience supporting audits, DHF documentation, verification evidence, or regulatory submissions is highly preferred.Preferred Skills:- Jama Connect.- Cloud, distributed, or edge-based systems.- Cybersecurity testing and vulnerability verification.- Containers and networking.- Authentication and security concepts.- Linux and Windows.- ISTQB certification.- Experience working with regulated product development environments.Education:- Bachelor's or Master's degree in Computer Science, Software Engineering, Biomedical Engineering, Information Technology, or Electronics/related engineering discipline.Key Competencies:- Strong analytical and problem-solving skills.- Excellent attention to detail.- Strong quality and compliance mindset.- Good communication and collaboration skills.- Ability to work independently in cross-functional teams.- Solid automation and continuous-improvement mindset.- Sound knowledge of SDLC and Software V&V.; (ref:hirist.tech)

📌 Software Quality Engineer - Medical Device Software (Pune)
🏢 Sunovaa Tech
📍 Pune