Software Quality Engineer

This is a fully remote position, open to applicants in India.

📋 Description

• Validate eCOA study software and review, approve, and uphold Computer System Validation (CSV) documentation in alignment with SOPs and work instructions.

• Examine requirements, specifications, and project documentation to pinpoint testability issues, inconsistencies, risks, and quality gaps.

• Collaborate with developers, study implementation managers, and other stakeholders to grasp project requirements and define suitable testing strategies.

• Create and sustain test cases, test data, and validation documentation while ensuring comprehensive traceability between requirements and testing activities.

• Conduct functional, integration, regression, and performance testing activities and document results with clear and meaningful evidence.

• Analyze test results, identify and report defects, evaluate impact and severity, and aid in defect resolution through retesting and verification activities.

• Configure, maintain, and support test environments and related testing tools essential for project execution.

• Develop and maintain testing documentation to support audits, inspections, and compliance with regulatory requirements.

• Oversee testing activities for assigned projects, track timelines, provide status updates, identify risks, and escalate issues as needed.

• Contribute to test planning, effort estimation, resource forecasting, and prioritization of testing activities.

• Maintain test data and assist in validation activities across various study modalities and software releases.

• Utilize defect tracking, test management, document management, and automation tools to enhance efficiency and quality.

• Support discussions on test strategy, root cause analysis, corrective and preventive action (CAPA) initiatives, and continuous process improvement efforts.

• Collaborate effectively with global and offshore teams while contributing to departmental objectives, 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 experience in software testing, software quality assurance, or validation.

• Understanding of the software development lifecycle (SDLC), quality assurance methodologies, and software testing principles.

• Experience in designing and executing functional, integration, and regression testing activities.

• Knowledge of validation practices, testing documentation, defect management, and requirements traceability.

• Experience 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 principles of audit-ready documentation is preferred.

• Working knowledge of defect tracking, test management, document management, and automation tools.

• Exposure to Agile development methodologies and modern software delivery practices is preferred.

• ISTQB Foundation Level certification or equivalent testing certification is preferred.

• Strong analytical and problem-solving abilities with the capacity to identify issues, assess risks, and propose solutions.

• Proficient written and verbal English communication skills, with 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.