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Bioclinica
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Software Quality Engineer (V&V)

Software Quality Engineer (V&V)

Bioclinica

0 - 5 years

2 - 7 Lacs

bengaluru

Posted:2 weeks ago| Platform:

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Skills Required

environment management backend risk assessment test management clinical trials agile healthcare software quality continuous improvement information technology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Join our innovative Digital Physiology team supporting the Respiratory business unit, where you ll play a key role in validating and assuring the quality of software used in respiratory clinical studies. As a Software Quality Engineer , you ll take ownership of the testing lifecycle from reviewing and approving Computer System Validation (CSV) packages to executing test strategies that meet regulatory and clinical standards. This hands-on role offers the opportunity to work on impactful projects that directly support patient outcomes, while collaborating with global teams in a fast-paced, agile environment.

What We Offer

Competitive compensation + shift allowances
Attractive benefits (security, flexibility, support, and well-being)
Engaging employee programs
Technology for hybrid working and excellent onsite facilities

What You ll Be Doing

Quality Reviews & Risk Assessment

Review specifications and documentation for clarity, consistency, and testability
Identify quality gaps and provide feedback to internal and external stakeholders
Assess risks and recommend mitigation strategies

Test Design & Execution

Define test goals and design functional, integration, and performance test cases
Ensure traceability between requirements, test cases, and documentation
Execute test cases, manage test data, and generate test evidence

Defect Management & Analysis

Identify, document, and track bugs with clear reproduction steps
Perform root cause analysis and prioritize bug retesting
Report deviations and ensure resolution

Documentation & Compliance

Create and maintain test documentation aligned with SOPs and regulatory standards
Support audits and follow Good Clinical Practices

Project & Test Management

Plan and monitor testing activities across multiple projects
Assign tasks, manage timelines, and escalate risks as needed
Provide timely status updates to stakeholders

Tool & Environment Management

Set up and maintain test environments and backend systems
Work with tools including bug tracking, test management, and automation suites
Recommend improvements to tools and processes

Collaboration & Leadership

Mentor and train new team members
Collaborate with offshore teams and cross-functional departments
Participate in cross-training and departmental initiatives

Continuous Improvement & Strategy

Contribute to test strategy development and process optimization
Participate in CAPA sessions and root cause analysis
Stay informed on industry trends in software, healthcare, and regulatory domains

What We re Looking For

BS, BA or equivalent in Information Technology or related field
0 5 years of software testing experience
Intermediate understanding of the software development lifecycle
ISTQB Foundation Level certification (optional)
Strong English communication skills
Novice to intermediate knowledge of test automation and Agile methodologies

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Bioclinica

Pharmaceutical Manufacturing

Princeton New Jersey

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Software Quality Engineer (V&V)