Software Quality Engineer II

Clario; India; On-site; INR 1,200,000 - 2,500,000; Full time

Benefits offered by this job

Competitive pay

Provident fund

Medical insurance

Remote work flexibility

Career growth

Job summary

Clario is seeking a Software Quality Engineer II to validate eCOA study software, review CSV deliverables, and drive high-quality releases across projects. You will design test strategies, execute diverse testing types, and collaborate with developers, study teams, and clients to ensure quality standards are met.

The role emphasizes regulated healthcare technology expertise, CAPA participation, and mentoring junior testers while supporting continuous process improvements in a global environment.

Qualifications

• Bachelor’s degree or equivalent practical experience in a technical field.
• 3–5 years of software quality assurance/testing experience.
• Strong understanding of SDLC and QA principles.
• Experience with CSV and regulated environments preferred.
• Excellent English communication and cross-functional collaboration.

Responsibilities

• Validate eCOA software and CSV deliverables per SOPs and work instructions.
• Review specs and project docs to identify testability gaps and risks.
• Design test strategies, cases, data, and validation approaches with traceability.
• Execute functional, integration, regression, performance and UAT tests and document results.
• Analyze defects, assess risk, and work with devs to resolve issues.
• Manage defect lifecycle, reporting, retesting, and root cause analysis support.
• Set up and maintain testing environments and tools.
• Prepare testing docs for audits and inspections.
• Lead testing efforts across projects and estimate timelines.
• Collaborate with stakeholders to ensure software quality expectations are met.
• Participate in process improvements and CAPA activities.
• Mentor juniors and promote continuous improvement.

Skills

QA testing

CSV

Agile

Test automation

Documentation

SDLC

CAPA

English communication

Education

Bachelor’s degree in IT/CS

Tools

Jira

TestRail

Selenium

Postman

Job description

Join Clario, a part of Thermo Fisher Scientific and help ensure the quality, reliability, and regulatory compliance of innovative electronic Clinical Outcome Assessment (eCOA) solutions used in clinical trials around the world.

As a Software Quality Engineer II, you will play a key role in validating study software, leading testing activities, reviewing Computer System Validation (CSV) documentation, and ensuring high-quality releases across multiple projects.

This position offers the opportunity to collaborate with cross-functional teams, influence testing strategy, and contribute to continuous process improvements within a regulated healthcare technology environment.

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 development and career growth within a global organization

What You’ll Be Doing

• Validate eCOA study software and review, approve, and maintain Computer System Validation (CSV) deliverables in accordance with applicable SOPs and work instructions.


• Review specifications, requirements, and project documentation to identify testability concerns, inconsistencies, risks, and quality gaps.


• Design comprehensive test strategies, test cases, test data, and validation approaches that ensure complete requirements traceability.


• Execute functional, integration, regression, performance, and user acceptance testing activities while creating meaningful test evidence and documentation.


• Analyze test results, identify defects, assess risk and severity, and collaborate with development teams to resolve issues effectively.


• Manage defect lifecycle activities, including reporting, investigation, retesting, prioritization, and root cause analysis support.


• Establish, configure, and maintain testing environments, tools, and supporting systems required for project execution.


• Prepare and maintain testing documentation that supports internal, client, and regulatory audits and inspections.


• Lead testing efforts across multiple projects by planning activities, monitoring timelines, managing priorities, identifying risks, and communicating project status to stakeholders.


• Estimate testing effort, resource requirements, and project timelines to support successful project delivery.


• Collaborate with developers, study implementation teams, product stakeholders, and customers to ensure software quality expectations are met.


• Participate in test strategy development, process improvement initiatives, corrective and preventive action (CAPA) activities, and departmental projects.


• Mentor junior team members, share best practices, and contribute to a culture of continuous improvement and operational excellence.

What We Look For

• Bachelor’s degree in Information Technology, Computer Science, Software Engineering, or a related technical field, or equivalent practical experience.


• 3 to 5 years of software quality assurance, software testing, or validation experience.


• Strong understanding of software development lifecycle (SDLC), software testing methodologies, and quality assurance principles.


• Experience developing and executing functional, integration, regression, and performance testing activities.


• Experience working within regulated environments, including healthcare, life sciences, medical device, clinical research, or pharmaceutical industries preferred.


• Knowledge of Computer System Validation (CSV), Good Clinical Practice (GCP), and audit-ready documentation principles preferred.


• Experience using defect tracking, test management, document management, and test automation tools.


• Working knowledge of Agile development methodologies and modern software delivery practices.


• ISTQB Advanced Test Analyst certification or related testing certification preferred.


• Strong analytical and problem-solving skills with the ability to identify risks and recommend effective mitigation strategies.


• Excellent verbal and written English communication skills and the ability to work effectively with global and offshore teams.


• Demonstrated 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.

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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.