Freelance Project: QA Engineer - Software Validation

We are looking for an experienced QA Engineer to support our team on a freelance basis. The ideal candidate will have expertise in software validation for regulated environments (e.g., medical devices, pharmaceuticals) and a strong understanding of GAMP 4/5 compliance.

If you have experience with Zephyr for test management and Cypress for automated testing, this project offers a great opportunity to contribute to high-quality, compliant software solutions.

Your deliverables are

Software Quality Assurance & Testing

• Develop and execute test plans, test cases, and test scripts for software validation.
• Perform functional, regression, integration, and system testing to ensure software quality.
• Work closely with developers to identify and resolve defects.

GAMP 4/5 Software Validation

• Validate software applications based on GAMP 4/5 guidelines.
• Document validation processes, including risk assessments, traceability matrices, and test reports.
• Ensure software meets compliance standards such as FDA, EMA, or ISO regulations.

Test Management with Zephyr

• Use Zephyr to manage test cases, track testing progress, and report results.
• Ensure proper documentation and traceability for audit purposes.

Automation with Cypress

• Develop and maintain automated test scripts using Cypress.
• Automate repetitive testing and integrate with CI/CD pipelines.

Collaboration & Reporting

• Work remotely with developers, project managers, and regulatory teams.
• Provide clear testing reports, defect logs, and validation documentation.
• Participate in project meetings as needed.

Your experience

• Proven experience as a QA Engineer specializing in software validation in regulated industries.
• Strong knowledge of GAMP 4/5 software validation principles.
• Proficiency in Zephyr for test management and Cypress for automated testing.
• Experience in manual and automated functional, regression, and system testing.
• Ability to document validation activities with full traceability.
• Strong problem-solving skills and attention to detail.
• Excellent communication skills (written and verbal).

Preferred Qualifications

• Experience working with FDA, EMA, ISO compliance requirements.
• Familiarity with additional testing tools/frameworks like Selenium, JUnit, or TestNG.
• Knowledge of CI/CD pipelines and automation integration.
• Experience with Python or JavaScript for test automation.
• Previous experience in medical device software validation or other regulated environments.

How to apply

If you are a freelance QA Engineer with expertise in GAMP 4/5 validation, Zephyr, and Cypress, we’d love to hear from you! Please share your portfolio/CV, availability, and hourly/project rates when applying.
Let’s work together to ensure high-quality, compliant software solutions!

EMSERE is a clinical trial solutions partner that provides quality services, equipment and supplies to ensure clinical trials run effortlessly from start to finish. By working closely with our clients, understanding their study protocol’s challenges and helping them plan to avoid potential pitfalls, EMSERE’s equipment, supplies, software and support aims to contribute to the success of our clients’ clinical trials.

At Emsere we foster the strengths of our informal family culture with a flat-structured organization and a spirit of entrepreneurship. Here, your personal growth is intertwined with the evolution of our company.
EMSERE’s culture is defined by our core values of customer focus, service expertise and commitment to quality. We are passionate about improving both the development process of new therapies and the lives of patients. With our key competences we work together with our internal and external stakeholders. 

Our key competences:

• Teamwork
• Flexibility
• Critical Thinking
• Individual Accountability
• Constructive Feedback

We have locations in Leiden (NL), Atlanta (US) and Singapore. The Leiden office has 70 employees at this point.