Software Quality Engineer II

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

📋 Description

• Validate eCOA study software while reviewing, approving, and maintaining Computer System Validation (CSV) deliverables in compliance with relevant SOPs and work instructions.

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

• Create comprehensive test strategies, test cases, test data, and validation methodologies to ensure thorough requirements traceability.

• Conduct functional, integration, regression, performance, and user acceptance testing, while generating test evidence and documentation.

• Evaluate test outcomes, identify defects, assess risk and severity, and work closely with development teams to address issues.

• Oversee defect lifecycle processes, including reporting, investigation, retesting, prioritization, and providing root cause analysis support.

• Set up, configure, and maintain testing environments, tools, and supporting systems.

• Prepare and manage testing documentation for internal, client, and regulatory audits and inspections.

• Lead testing initiatives across multiple projects by planning activities, tracking timelines, managing priorities, identifying risks, and communicating project updates.

• Estimate testing efforts, resource needs, and project timelines.

• Collaborate with developers, implementation teams, product stakeholders, and customers to fulfill software quality expectations.

• Engage in test strategy formulation, process enhancement 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 experience in software quality assurance, software testing, or validation.

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

• Proven experience in developing and executing functional, integration, regression, and performance testing activities.

• Experience in regulated sectors such as healthcare, life sciences, medical devices, clinical research, or the pharmaceutical industry is preferred.

• Familiarity with Computer System Validation (CSV), Good Clinical Practice (GCP), and principles of audit-ready documentation is preferred.

• Proficiency in using defect tracking, test management, document management, and test automation tools.

• Working knowledge of Agile development methodologies and contemporary software delivery practices.

• ISTQB Advanced Test Analyst certification or a related testing certification is preferred.

• Strong analytical and problem-solving abilities with the capacity to identify risks and suggest mitigation strategies.

• Excellent verbal and written communication skills in English, with the ability to collaborate effectively with global and offshore teams.

• Capability to manage multiple priorities, work independently, meet deadlines, and maintain accuracy and attention to detail.

🏝️ Benefits

• Competitive salary and performance incentives.

• Provident fund and health insurance coverage.

• Engaging employee programs and local events.

• Modern office environments and flexibility for remote work.

• Opportunities for professional growth and career advancement within a global organization.