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.
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.
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.
