Senior Software Quality Assurance Engineer
Zimmer Biomet13 days ago
Bengaluru, IndiaSenior
Responsibilities
- Perform software quality reviews of requirements, designs, and deliverables for compliance with FDA, ISO, and IEC 62304 standards.
- Review and approve requirements specifications, test plans, validation protocols, traceability matrices, and validation reports.
- Ensure end-to-end traceability between requirements, risk controls, and verification evidence.
- Participate in risk assessments, design reviews, code reviews, and quality reviews.
- Develop and execute test plans, test cases, and validation protocols for verification and validation activities.
- Perform functional, integration, and system-level testing for embedded software and cloud-based systems.
- Support change management, defect investigations, audit readiness, and regulatory inspections.
Requirements
- Bachelor’s degree in computer science, computer engineering, or a related field.
- At least 5 years of software validation and quality experience in a regulated environment; medical-device experience is preferred.
- Strong understanding of software verification and validation principles, test coverage, and objective evidence.
- Experience with validation deliverables such as test plans, validation protocols, execution reports, and traceability matrices.
- Familiarity with ISO 14971 risk management, change management, configuration management, version control, and release traceability.
- Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
- Experience working with cross-functional R&D, QA, and Regulatory teams.
Benefits
- Flexible working arrangement with 2 work-from-home days and 3 work-from-office days in Bengaluru.
- Development opportunities, employee resource groups, wellness incentives, recognition programs, and performance awards.
- Up to 10% travel is expected.