Sr Software Quality Engineer (V&V)

At Clario, a part of Thermo Fisher Scientific, our Medical Imaging team delivers advanced technology and imaging solutions that support clinical trials across the globe.

As a Senior Software Quality Engineer (Verification and Validation), you will play a key role in validating study software, managing test activities, reviewing Computer System Validation (CSV) documentation, and ensuring high-quality, compliant software deliverables.

This role is ideal for an experienced software testing professional who thrives in a regulated environment, enjoys leading validation activities, and is motivated by improving quality, efficiency, and patient-focused clinical research outcomes.

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
• What You'll Be Doing
• Lead validation activities for study software in accordance with Standard Operating Procedures (SOPs), work instructions, Good Clinical Practice, and applicable regulatory expectations.
• Review and approve Computer System Validation packages, including test documentation, evidence, defects, and supporting materials.
• Review manuals, specifications, and project documentation for testability, clarity, completeness, consistency, risk, and quality gaps.
• Partner with developers, study implementation managers, and internal stakeholders to understand project requirements, software changes, risk areas, and mitigation plans.
• Define test objectives, design test cases, establish expected results, maintain traceability, and support integration, functional, regression, and performance testing.
• Execute test cases, create reliable test evidence, use appropriate test data, and compare expected and actual results to identify deviations.
• Document, classify, prioritize, investigate, and retest defects using applicable bug tracking processes and tools.
• Set up, maintain, and update configured test environments, including backend systems and testing utilities.
• Create and review test documentation required for audits, inspections, internal reviews, external reviews, and regulatory agency requests.
• Manage overall test effort across assigned projects, including planning, timelines, resourcing, quality, risks, escalations, and offshore team coordination.
• Estimate testing effort, prerequisites, resources, and timelines for upcoming validation activities and project deliverables.
• Maintain positive, negative, and boundary test data across applicable modalities and testing scenarios.
• Use test management systems, document management systems, bug tracking systems, screenshot tools, and test automation suites to support efficient validation delivery.
• Provide accurate status updates on testing progress, open items, defects, risks, and project commitments to internal and external stakeholders.
• Support test strategy development, user acceptance testing, customer calls, internal and external audits, and root cause analysis or corrective and preventive action activities.
• Identify opportunities to improve testing processes, tools, efficiency, effectiveness, and overall quality.
• Mentor and train team members, share testing knowledge, support cross-training, and contribute to departmental goals and continuous improvement.
• What We Look For
• Bachelor of Technology degree or equivalent qualification in Information Technology, Computer Science, Engineering, or a related field.
• 5-10 years of software testing, software quality engineering, validation, or verification and validation experience.
• Advanced understanding of the software development lifecycle, software testing principles, and regulated validation practices.
• Experience managing testing activities across multiple projects, including planning, task assignment, timeline management, risk escalation, and quality oversight.
• Strong experience designing, executing, reviewing, and documenting functional, integration, regression, performance, and validation test cases.
• Experience with bug tracking systems, test management systems, document management systems, screenshot tools, and test automation suites.
• Knowledge of Computer System Validation, Good Clinical Practice, audit readiness, and regulated clinical research or healthcare technology environments.
• Advanced knowledge of Agile methodologies and test automation preferred.
• ISTQB Advanced Level Test Analyst certification preferred.
• Ability to work independently with limited supervision while collaborating effectively with onsite, offshore, cross-functional, and technical teams.
• Strong analytical, problem-solving, prioritization, and decision-making skills with excellent attention to detail.
• Excellent verbal and written communication skills in English, with the ability to present status, risks, findings, and recommendations clearly.
• Ability to work under pressure, manage multiple priorities, meet deadlines, and maintain accountability for high-quality results.
• Proactive, self-motivated approach to learning, mentoring, process improvement, and continuous professional development.

At Clario, 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 - 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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