Software Quality Engineer (V&V)

At Clario, part of Thermo Fisher Scientific, we develop regulated technology that helps unlock better evidence and improve patient outcomes worldwide. Our software platforms support clinical trials, diagnostics, and medical decision-making in highly controlled regulatory environments.

As a Software Quality Engineer (V&V), you will play a key role in validating clinical study software to ensure quality, compliance, and reliability. You will collaborate with cross-functional teams to deliver high-quality solutions that support clinical trials and ultimately improve patient outcomes.

• Competitive compensation

• Health, dental, and vision coverage

• 401(k) retirement plan with company match

• Paid time off and company holidays

• Flexible/remote work options

• Review software specifications and validation documentation to ensure clarity, completeness, and testability.

• Manage the full End-to-End (E2E) test cycle process, from initial test design through to final execution and evidence capture.

• Design and develop comprehensive test cases, including functional, integration, and performance scenarios.

• Execute manual test cases and manage accurate test data for validation activities within regulated environments.

• Manage the defect lifecycle utilizing Jira or similar ALM tools, ensuring clear root cause insights and prioritization.

• Collaborate with global project teams, specifically coordinating with team members in India; this requires comfort working across international time zones (CST to EST preferred).

• 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 and risks, providing clear status updates and escalations as needed.

• Identify opportunities to improve testing processes, tools, and overall quality practices.

• Bachelor’s degree in Information Technology or a related field, or equivalent practical experience.

• 3+ years in software testing or quality assurance, with a proven track record in End-to-End (E2E) testing.

• Proficiency with Jira or similar bug-tracking and test management software.

• High comfort level collaborating with offshore/global teams (specifically India) and managing the associated communication and scheduling needs.

• Proven understanding of the software development lifecycle (SDLC) and validation processes.

• Familiarity with documentation systems and a high attention to detail required for regulated environments.

• Based in or able to work remotely within the United States (CST or EST time zones preferred).

At Clario, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.