Software Quality Engineer (V&V)

Clario

1d•Remote

About The Position

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.

Requirements

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).

Responsibilities

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.