Software Quality Engineer II

Responsibilities

• Validate regulated clinical study software by reviewing requirements and specifications, designing and executing test cases, and ensuring full traceability across requirements, tests, and documentation.
• Plan, execute, and manage functional, integration, regression, and performance testing, including creation of test data and test evidence.
• Review, approve, and maintain CSV documentation in compliance with SOPs, Work Instructions, regulatory expectations, and Good Clinical Practice (GCP).
• Identify, document, and manage defects through the full lifecycle, including severity assessment, root cause analysis, retesting, and verification.
• Set up, maintain, and use validated test environments and testing tools, including test management, defect tracking, automation, and documentation systems.
• Estimate test effort, plan testing activities, manage timelines, and report status, risks, and quality metrics for one or multiple concurrent projects.
• Collaborate closely with developers, project teams, and global stakeholders to assess change impact, mitigate risk, and ensure high‑quality software releases.
• Support audits, inspections, UATs, and CAPA activities by providing accurate documentation and clear testing evidence.
• Contribute to test strategy development, process improvements, tool optimization, and departmental efficiency initiatives.
• Mentor junior team members, support cross‑functional collaboration, and share best practices across the organization.
• What We Look For
• Bachelor's degree in Information Technology or a related field, or equivalent experience.
• 3-5 years of hands‑on software testing experience in regulated or quality‑critical environments.
• Intermediate understanding of the Software Development Lifecycle (SDLC).
• Experience working with validated systems and CSV documentation.
• Familiarity with test automation concepts, Agile methodologies, and test management tools.
• Strong analytical skills, attention to detail, and commitment to quality.
• Ability to work independently, manage priorities, and meet deadlines under pressure.
• Very good English communication skills, both written and verbal.
• ISTQB Advanced Level Test Analyst certification is a plus.

Benefits

Additional Information

At Clario, a part of Thermo Fisher Scientific, the Software Quality Engineer II (SQE II) plays a hands‑on role in validating regulated clinical study software and ensuring software quality, compliance, and readiness for use in clinical trials. This role is responsible for executing and overseeing testing activities, reviewing and approving Computer System Validation (CSV) documentation in accordance with SOPs and Work Instructions, and ensuring quality, timelines, and risk management across assigned projects. The SQE II also contributes to departmental initiatives focused on continuous improvement, efficiency, and strengthening quality practices across teams and systems.

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