Senior Software Quality Assurance Engineer
RemoteFull-time5–9 yrsPosted 2 months ago
Senior QA and testing role at Zimmer Biomet. Needs 5+ years and a B.Tech, B.E. or B.Sc. Remote.
About the role
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.
What you'll do
- 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
What you need
- Test cases
- Root cause analysis