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.