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Software Quality Engineer II
ClarioSoftware Quality Engineer II at Clario validating regulated clinical study software through hands-on testing and ensuring compliance. Collaborating with teams to improve quality practices across systems.
Tech Stack
Tools & technologiesGoogle Cloud PlatformSDLC
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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
Comp & perks- Competitive compensation
- Provident Fund & Gratuity
- Flexible leave plans
- Flexible work schedules and shift allowances
- Engaging employee programs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
software testingtest case designdefect managementroot cause analysistest automationperformance testingregression testingfunctional testingtest data creationquality metrics
Soft Skills
analytical skillsattention to detailcommitment to qualityindependent workpriority managementdeadline managementcommunication skillsmentoringcollaborationprocess improvement
Certifications
Bachelor’s degree in Information TechnologyISTQB Advanced Level Test Analyst certification