Software Quality Engineer II

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Clario

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1973

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private Equity Round on 2019-10

Healthcare • Consulting • Logistics

Clario is a company specializing in accelerating clinical trials from initiation to implementation through advanced technologies and services. Since 2018, Clario has revolutionized endpoint analyses in clinical trials by integrating over 30 artificial intelligence-enabled solutions across more than 600 active trials, enhancing data quality and patient privacy while expediting data collection processes. Clario provides a comprehensive clinical trial management platform, offering solutions such as eCOA, cardiac safety, medical imaging, precision motion, and respiratory services in various therapeutic areas including oncology, cardiology, and neurology. Known for its global reach, Clario supports clinical trials in over 100 countries with a strong focus on decentralized and hybrid trial models. The company's commitment to patient safety and innovation is reflected in their over 26,000 trials and involvement in numerous new drug approvals.

📋 Description

• 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 ensuring complete requirements traceability • Execute functional, integration, regression, performance, and user acceptance testing and create test evidence and documentation • Analyze test results, identify defects, assess risk and severity, and collaborate with development teams to resolve issues • Manage defect lifecycle activities, including reporting, investigation, retesting, prioritization, and root cause analysis support • Establish, configure, and maintain testing environments, tools, and supporting systems • Prepare and maintain testing documentation for 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 • Estimate testing effort, resource requirements, and project timelines • Collaborate with developers, study implementation teams, product stakeholders, and customers to meet software quality expectations • Participate in test strategy development, process improvement initiatives, CAPA activities, and departmental projects • Mentor junior team members, share best practices, and contribute to continuous improvement and operational excellence

🎯 Requirements

• 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 within regulated environments such as 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 ability to identify risks and recommend mitigation strategies • Excellent verbal and written English communication skills and ability to work effectively with global and offshore teams • Ability to manage multiple priorities, work independently, meet deadlines, and maintain accuracy and attention to detail

🏖️ Benefits

• 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