Senior Software Quality Assurance Engineer

Job Summary

Detail-oriented Software Validation and Quality Engineer experience in regulated environments, specializing in software quality review, compliance, and audit readiness, with hands-on capability in validation and testing activities supporting FDA, IEC and ISO standards.

Location: Bengaluru Work mood: 2 WFH, 3 WFO

Principal Duties and Responsibilities:

Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304 standards.

Ensure adherence to quality system processes and design control requirements across the software development lifecycle.

Review and approve requirement specifications, test plans, validation protocols, traceability matrices (RTM), and validation reports.

Support requirements activities by ensuring clarity, completeness, and testability of software requirements.

Ensure end-to-end traceability between requirements, risk controls, and verification evidence.

Participate in risk assessments and ensure proper implementation and verification of risk control measures.

Participate in design reviews, code reviews, and quality reviews of software deliverables.

Support change management activities, including impact assessment and documentation of software changes.

Support validation and verification (V&V) activities by developing and executing test plans, test cases, and validation protocols as needed.