Review software specifications and validation documentation to ensure clarity, completeness, and testability
Design and develop comprehensive test cases, including functional, integration, and performance scenarios
Execute manual test cases, capture test evidence, and manage accurate test data for validation activities
Analyze test results, identify defects, and document reproducible issues with clear root cause insights
Collaborate with developers and project teams to validate new features and ensure regression coverage
Manage the defect lifecycle, including prioritization, retesting, and tracking within bug management systems
Maintain and configure test environments, including backend systems and supporting tools
Create and maintain validation documentation aligned with SOPs, regulatory standards, and Good Clinical Practices (GCP)
Support internal and external audits by preparing and providing required validation documentation
Monitor project timelines, risks, and testing progress, providing clear status updates and escalations as needed
Contribute to test planning, effort estimation, and coordination across multiple projects
Identify opportunities to improve testing processes, tools, and overall quality practices
Collaborate across teams, share knowledge, and support onboarding and mentoring of new team members

Bachelor’s degree in Information Technology or a related field, or equivalent practical experience
1–3 years of experience in software testing or quality assurance
Proven understanding of the software development lifecycle and validation processes
Experience designing and executing manual test cases and documenting results
Familiarity with defect tracking systems, test management tools, and documentation systems
Basic knowledge of test automation and Agile methodologies
Strong analytical and problem-solving skills with high attention to detail
Effective communication skills in English, both written and verbal
Ability to manage multiple priorities, meet deadlines, and work independently or collaboratively
Based in or able to work remotely within the United States

Software Quality Engineer – V&V

Key skills