About this role
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
• Engaging employee programs and local events
• Modern office spaces and remote work flexibility
• Opportunities for professional development and career growth within a global organization
What You’ll Be Doing
• Validate eCOA study software and review, approve, and maintain Computer System Validation (CSV) deliverables in accordance with applicable SOPs and work instructions.
• Review specifications, requirements, and project documentation to identify testability concerns, inconsistencies, risks, and quality gaps.
• Design comprehensive test strategies, test cases, test data, and validation approaches that ensure complete requirements traceability.
• Execute functional, integration, regression, performance, and user acceptance testing activities while creating meaningful test evidence and documentation.
• Analyze test results, identify defects, assess risk and severity, and collaborate with development teams to resolve issues effectively.
• Manage defect lifecycle activities, including reporting, investigation, retesting, prioritization, and root cause analysis support.
• Establish, configure, and maintain testing environments, tools, and supporting systems required for project execution.
• Prepare and maintain testing documentation that supports internal, client, and regulatory audits and inspections.
• Lead testing efforts across multiple projects by planning activities, monitoring timelines, managing priorities, identifying risks, and communicating project status to stakeholders.
• Estimate testing effort, resource requirements, and project timelines to support successful project delivery.
• Collaborate with developers, study implementation teams, product stakeholders, and customers to ensure software quality expectations are met.
• Participate in test strategy development, process improvement initiatives, corrective and preventive action (CAPA) activities, and departmental projects.
• Mentor junior team members, share best practices, and contribute to a culture of continuous improvement and operational excellence.
What We Look For
• Bachelor’s degree in Information Technology, Computer Science, Software Engineering, or a related technical field, or equivalent practical experience.
• 3 to 5 years of software quality assurance, software testing, or validation experience.
• Strong understanding of software development lifecycle (SDLC), software testing methodologies, and quality assurance principles.
• Experience developing and executing functional, integration, regression, and performance testing activities.
• Experience working within regulated environments, including healthcare, life sciences, medical device, clinical research, or pharmaceutical industries preferred.
• Knowledge of Computer System Validation (CSV), Good Clinical Practice (GCP), and audit-ready documentation principles preferred.
• Experience using defect tracking, test management, document management, and test automation tools.
• Working knowledge of Agile development methodologies and modern software delivery practices.
• ISTQB Advanced Test Analyst certification or related testing certification preferred.
• Strong analytical and problem-solving skills with the ability to identify risks and recommend effective mitigation strategies.
• Excellent verbal and written English communication skills and the ability to work effectively with global and offshore teams.
• Demonstrated ability to manage multiple priorities, work independently, meet deadlines, and maintain a high level of accuracy and attention to detail.
At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.