Software Quality Engineer

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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) documentation in accordance with SOPs and work instructions • Review requirements, specifications, and project documentation to identify testability concerns, inconsistencies, risks, and quality gaps • Partner with developers, study implementation managers, and other stakeholders to understand project requirements and define appropriate testing strategies • Design and maintain test cases, test data, and validation documentation while ensuring end-to-end traceability between requirements and testing activities • Execute functional, integration, regression, and performance testing activities and document results with clear and meaningful evidence • Analyze test outcomes, identify and report defects, assess impact and severity, and support defect resolution through retesting and verification activities • Configure, maintain, and support test environments and associated testing tools required for project execution • Create and maintain testing documentation to support audits, inspections, and regulatory compliance requirements • Manage testing activities for assigned projects, monitor timelines, communicate status updates, identify risks, and escalate issues when necessary • Contribute to test planning, effort estimation, resource forecasting, and prioritization of testing activities • Maintain test data and support validation activities across multiple study modalities and software releases • Utilize defect tracking, test management, document management, and automation tools to improve efficiency and quality • Support test strategy discussions, root cause analysis activities, corrective and preventive action (CAPA) initiatives, and continuous process improvement efforts • Collaborate effectively with global and offshore teams while contributing to departmental goals, knowledge sharing, and cross-functional initiatives

🎯 Requirements

• Bachelor’s degree in Information Technology, Computer Science, Software Engineering, or a related technical field, or equivalent practical experience • 1 to 3 years of software testing, software quality assurance, or validation experience • Understanding of software development lifecycle (SDLC), quality assurance methodologies, and software testing principles • Experience designing and executing functional, integration, and regression testing activities • Knowledge of validation practices, testing documentation, defect management, and requirements traceability • Experience working in regulated environments such as healthcare, life sciences, clinical research, medical devices, or pharmaceutical industries is preferred • Familiarity with Computer System Validation (CSV), Good Clinical Practice (GCP), and audit-ready documentation principles is preferred • Working knowledge of defect tracking, test management, document management, and automation tools • Exposure to Agile development methodologies and modern software delivery practices preferred • ISTQB Foundation Level certification or equivalent testing certification preferred • Strong analytical and problem-solving skills with the ability to identify issues, evaluate risks, and recommend solutions • Good written and verbal English communication skills and the ability to collaborate with global and offshore teams • Ability to manage multiple priorities, work independently, meet deadlines, and maintain a high level of accuracy and attention to detail

🏖️ Benefits

• Competitive pay and incentives • Provident fund • Medical insurance • Engaging employee programs and local events • Modern office spaces and remote work flexibility • Opportunities for professional growth and development within a global organization