Software Validation Engineer

• 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

Benefits:

• Health insurance
• Leave encashment
• Life insurance
• Provident Fund

Education:

• Master's (Required)

Experience:

• Software testing: 5 years (Required)

Work Location: In person