Software Quality Engineer II
Join Clario , a part of Thermo Fisher Scientific and help ensure the quality, reliability, and regulatory compliance of innovative electronic Clinical Outcome Assessment (eCOA) solutions used in clinical trials around the world. As a Software Quality Engineer II, you will play a key role in validating study software, leading testing activities, reviewing Computer System Validation (CSV) documentation, and ensuring high-quality releases across multiple projects. This position offers the opportunity to collaborate with cross-functional teams, influence testing strategy, and contribute to continuous process improvements within a regulated healthcare technology environment.
What We Offer
- Competitive pay and incentives
- Provident fund and medical insurance
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Engaging employee programs and local events
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Modern office spaces and remote work flexibility
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Opportunities for professional development and career growth within a global organization
What You’ll Be Doing
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Validate eCOA study software and review, approve, and maintain Computer System Validation (CSV) deliverables in accordance with applicable SOPs and work instructions.
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Review specifications, requirements, and project documentation to identify testability concerns, inconsistencies, risks, and quality gaps.
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Design comprehensive test strategies, test cases, test data, and validation approaches that ensure complete requirements traceability.
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Execute functional, integration, regression, performance, and user acceptance testing activities while creating meaningful test evidence and documentation.
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Analyze test results, identify defects, assess risk and severity, and collaborate with development teams to resolve issues effectively.
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Manage defect lifecycle activities, including reporting, investigation, retesting, prioritization, and root cause analysis support.
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Establish, configure, and maintain testing environments, tools, and supporting systems required for project execution.
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Prepare and maintain testing documentation that supports internal, client, and regulatory audits and inspections.
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Lead testing efforts across multiple projects by planning activities, monitoring timelines, managing priorities, identifying risks, and communicating project status to stakeholders.
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Estimate testing effort, resource requirements, and project timelines to support successful project delivery.
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Collaborate with developers, study implementation teams, product stakeholders, and customers to ensure software quality expectations are met.
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Participate in test strategy development, process improvement initiatives, corrective and preventive action (CAPA) activities, and departmental projects.
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Mentor junior team members, share best practices, and contribute to a culture of continuous improvement and operational excellence.
What We Look For
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Bachelor’s degree in Information Technology, Computer Science, Software Engineering, or a related technical field, or equivalent practical experience.
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3 to 5 years of software quality assurance, software testing, or validation experience.
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Strong understanding of software development lifecycle (SDLC), software testing methodologies, and quality assurance principles.
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Experience developing and executing functional, integration, regression, and performance testing activities.
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Experience working within regulated environments, including healthcare, life sciences, medical device, clinical research, or pharmaceutical industries preferred.
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Knowledge of Computer System Validation (CSV), Good Clinical Practice (GCP), and audit-ready documentation principles preferred.
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Experience using defect tracking, test management, document management, and test automation tools.
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Working knowledge of Agile development methodologies and modern software delivery practices.
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ISTQB Advanced Test Analyst certification or related testing certification preferred.
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Strong analytical and problem-solving s