Develop, review, and execute Software Validation Plans (SVP), Validation Protocols, and Validation Reports.
Analyze software requirements, design specifications, and risk management documents to create validation strategies and test cases.
Perform software verification and validation (V&V;) activities in accordance with FDA 21 CFR Part 820, FDA Software Guidance, IEC 62304, ISO 13485, and applicable regulatory requirements.
Design and execute functional, integration, system, regression, and user acceptance testing.
Create and maintain Requirements Traceability Matrices (RTM) linking requirements, risks, test cases, and validation evidence.
Support software lifecycle processes and documentation in compliance with medical device quality management systems.
Participate in software risk assessments and hazard analysis activities in accordance with ISO 14971.
Investigate, document, and track software defects, non-conformances, and CAPA-related activities.




Review software change requests and assess validation impact for software enhancements, patches, and releases.
Ensure proper documentation of validation evidence, protocols, deviations, and test results for regulatory audits and inspections.
Collaborate with Software Development, Quality Assurance, Regulatory Affairs, and Manufacturing teams throughout the product lifecycle.
Support internal audits, external audits, FDA inspections, and notified body assessments.
Participate in continuous improvement initiatives to enhance software validation processes and compliance.

Pay: ₹800,000.00 - ₹1,000,000.00 per year

Advantages:
Health insurance
Leave encashment
Life insurance
Provident Fund

Education:
Master's (Required)

Experience:
Software testing: 5 years (Required)

Work Location: In person

📌 Software Validation Engineer Chennai
🏢 Trustin Analytical Solutions
📍 Chennai