Software Quality Engineer II

clarioclinical; India; Hybrid; INR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Provident fund and medical insurance

Remote work flexibility

Professional development & career рост

Modern offices

Job summary

Clario is seeking a Software Quality Engineer II to validate study software, lead testing activities, and review CSV documentation within a regulated healthcare technology environment. You will design test strategies and execute functional, integration, regression, and performance tests while ensuring traceability and quality across projects.

Ideal candidates have 3–5 years in software QA, familiarity with CSV, GCP, and audit-ready documentation, and strong English communication for global

Qualifications

• Bachelor’s degree or equivalent practical experience in a technical field.
• 3–5 years of software quality assurance, software testing, or validation experience.
• Experience in regulated environments (healthcare, life sciences, medical device, clinical research or pharmaceutical) preferred.
• Knowledge of CSV, GCP, and audit-ready documentation principles preferred.
• Experience using defect tracking, test management, document management, and test automation tools.
• Excellent English communication skills and ability to work with global/offshore teams.

Responsibilities

• Validate eCOA study software and CSV deliverables per SOPs/work instructions.
• Design test strategies, cases, data, and validation approaches ensuring traceability.
• Execute functional, integration, regression, and performance testing, with evidence.
• Analyze results, identify defects, and coordinate with development teams to resolve issues.
• Maintain testing environments, documentation for audits, and CAPA considerations.
• Lead testing across multiple projects, plan activities, manage priorities, and report status.

Skills

Software testing

CSV knowledge

SDLC understanding

Agile methods

Test strategies

Defect lifecycle

Regulated environments

Analytical skills

Education

Bachelor's degree in IT/CS/SE

Tools

Test management tools

Defect tracking tools

Document management tools

Test automation tools

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.