Software Quality Sr Engineer
$100k - $124kZimmer Biomet
Zimmer Biomet seeks a senior software quality engineer to oversee validation, compliance, and quality assurance activities for medical device software in regulated environments. The remote role involves reviewing requirements and deliverables against FDA, ISO, and IEC standards, supporting the full software development lifecycle.
Responsibilities
- Perform software quality review of requirements, design, and deliverables for regulatory compliance
- Review and approve requirement specifications, test plans, validation protocols, and traceability matrices
- Develop and execute test cases and validation protocols for embedded and cloud-based systems
- Support defect investigations, root cause analysis, and risk assessment activities
- Ensure end-to-end traceability between requirements, risk controls, and verification evidence
Requirements
- Bachelor's degree in computer science, engineering, or related field
- 4+ years software validation and quality experience in regulated environments
- Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11
- Experience with validation deliverables: test plans, protocols, RTM, and reports
- Familiarity with risk management processes and ISO 14971 standards
- Experience in design reviews, code reviews, and quality reviews
Compensation: $100,000 - $124,000 USD / Annual
Vacancy posted 8 days ago
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