Software Quality Engineer

US Biomedical Systems India Pvt Ltd.; India; On-site; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive pay and incentives

Provident fund and medical insurance

Engaging employee programs and local‑s

Modern office spaces and remote work

Opportunities for professional growth

Job summary

Clario, a part of Thermo Fisher Scientific, is seeking a Software Quality Engineer to validate eCOA study software, review CSV documentation, and drive testing across projects.

You will design test cases, execute tests, document evidence, and collaborate with global teams to ensure compliant, high-quality releases.

Qualifications

• Bachelor’s degree in IT/CS or related technical field.
• 1–3 years in software testing/QA/validation.
• Understanding of SDLC and QA methodologies.
• Experience with validation practices and traceability.
• Familiarity with regulated environments (healthcare/life sciences) preferred.

Responsibilities

• Validate eCOA study software and review CSV documentation per SOPs.
• Identify testability issues, risks, and quality gaps.
• Define testing strategies with developers and managers.
• Design and maintain test cases and data with end-to-end traceability.
• Execute functional, integration, and regression tests; document results.
• Analyze results, report defects, and support verification.
• Maintain test environments and testing tools for projects.
• Create testing docs for audits and regulatory requirements.
• Monitor timelines, communicate status, and manage risks.

Skills

Software testing

CSV validation

SDLC knowledge

Regulatory compliance

Test planning

Evidence/documentation

Analytical thinking

Team collaboration

Education

Bachelor’s degree in Information Technology/Computer Science/Software Engineering

Job description

Join Clario, a part of Thermo Fisher Scientific and help deliver high-quality, compliant eCOA solutions that support clinical trials around the world. As a Software Quality Engineer, you will play a hands‑on role in validating study software, reviewing Computer System Validation (CSV) documentation, and ensuring the successful execution of testing activities across multiple projects. You will take ownership of assigned studies, proactively remove roadblocks, drive quality outcomes, and collaborate with cross‑functional teams to ensure software releases meet regulatory, business, and customer expectations.

What We Offer

• Competitive pay and incentives
• Provident fund and medical insurance
• Engaging employee programs and local events
• Modern office spaces and remote work flexibility
• Opportunities for professional growth and development within a global organization

What You’ll Be Doing

• Validate eCOA study software and review, approve, and maintain Computer System Validation (CSV) documentation in accordance with SOPs and work instructions.
• Review requirements, specifications, and project documentation to identify testability concerns, inconsistencies, risks, and quality gaps.
• Partner with developers, study implementation managers, and other stakeholders to understand project requirements and define appropriate testing strategies.
• Design and maintain test cases, test data, and validation documentation while ensuring end‑to‑end traceability between requirements and testing activities.
• Execute functional, integration, regression testing activities and document results with clear and meaningful evidence.
• Analyze test outcomes, identify and report defects, assess impact and severity, and support defect resolution through retesting and verification activities.
• Configure, maintain, and support test environments and associated testing tools required for project execution.
• Create and maintain testing documentation to support audits, inspections, and regulatory compliance requirements.
• Manage testing activities for assigned projects, monitor timelines, communicate status updates, identify risks, and escape issues when necessary.
• Contribute to test planning, effort estimation, resource forecasting, and prioritization of testing activities.
• Maintain test data and support validation activities across multiple study modalities and software releases.
• Utilize defect tracking, test management, document management, and automation tools to improve efficiency and quality.
• Support test strategy discussions, root cause analysis activities, corrective and preventive action (CAPA) initiatives, and continuous process improvement efforts.
• Collaborate effectively with global and offshore teams while contributing to departmental goals, knowledge sharing, and cross‑functional initiatives.

What We Look For

• Bachelor’s degree in Information Technology, Computer Science, Software Engineering, or a related technical field, or equivalent practical experience.
• 1 to 3 years of software testing, software quality assurance, or validation experience.
• Understanding of software development lifecycle (SDLC), quality assurance methodologies, and software testing principles.
• Experience designing and executing functional, integration, and regression testing activities.
• Knowledge of validation practices, testing documentation, defect management, and requirements traceability.
• Experience working in regulated environments such as healthcare, life sciences, clinical research, medical devices, or pharmaceutical industries is preferred.
• Familiarity with Computer System Validation (CSV), Good Clinical Practice (GCP), and audit‑ready documentation principles is preferred.
• Working knowledge of defect tracking, test management, document management, and automation tools.
• Exposure to Agile development methodologies and modern software delivery practices preferred.
• ISTQB Foundation Level certification or equivalent testing certification preferred.
• Strong analytical and problem‑solving skills with the ability to identify issues, evaluate risks, and recommend solutions.
• Good written and verbal English communication skills and the ability to collaborate with global and offshore teams.
• Ability to manage multiple priorities, work independently, meet deadlines, and maintain a high level of accuracy and attention to detail.

At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, 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.

Clario Privacy Policy Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high‑quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints. For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.