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​ Senior Software Quality Assurance Engineer

Zimmer Biomet·Remote

Pay not stated5–9 yrsFull-timeRemote
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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

  • 5–9 yrs of experience
  • Test cases
  • Root cause analysis
  • B.Tech or B.E. or B.Sc or BCA

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