Software Quality Engineer

The Software Quality Engineer is responsible for designing, developing, and maintaining automated test frameworks and scripts to ensure the quality and performance of our web-based EDC solutions. You will collaborate with developers, product managers, and QA analysts to build scalable test automation suites that support continuous integration and delivery (CI/CD) pipelines. The Software Quality Engineer will implement and maintain best-in-class quality assurance (QA) processes that align with industry standards such as GxP, 21 CFR Part 11, and ISO 9001.

QUALIFICATIONS

Bachelor’s degree in Computer Science, Software Engineering, Information Technology, or a related field. Experience in software quality assurance or software quality engineering, preferably in a CRO or EDC setting. 3+ years of experience in software test automation, preferably in the healthcare or life sciences industry. Familiarity with testing tools such as Selenium WebDriver, TestNG, JUnit, Postman, or similar. Experience with version control (e.g., Git) and Agile/Scrum methodologies. Strong understanding of software QA methodologies, tools, and processes.

KEY RESPONSIBILITIES

Design and develop automated test scripts for web and API layers using tools such as Selenium, Playwright, or Cypress. Collaborate with development teams to integrate automated tests into CI/CD workflows (e.g., GitLab CI, Jenkins, GitHub Actions). Create and maintain test plans, test cases, and test data based on product requirements and clinical workflows. Participate in requirements reviews and contribute to risk-based testing strategies specific to regulatory and GCP-compliant environments. Identify, document, and track software defects using tools like JIRA or Azure DevOps. Conduct performance and load testing to validate scalability of EDC modules. Maintain high test coverage across components handling clinical trial data capture, validation, audit trails, and regulatory reporting. Support validation documentation and contribute to traceability matrices in accordance with 21 CFR Part 11 and GAMP 5. Collaborate with software developers and other stakeholders to define software quality requirements. Conduct software validation activities in compliance with applicable regulatory standards. Identify, document, and track software defects and work with development teams to resolve issues. Perform risk assessments and ensure compliance with industry regulations related to software quality and validation. Support software release activities by ensuring all quality and compliance criteria are met before deployment. Maintain and improve software testing processes, methodologies, and best practices. Assist in the preparation and review of Standard Operating Procedures (SOPs) and software documentation. Participate in internal and external audits related to software validation and quality assurance. Performs other duties as assigned.

LOCATION AND TRAVEL REQUIREMENTS

This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic and international travel may be required for company meetings, audits, etc. * This Company participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. #J-18808-Ljbffr Hrcrs