Senior Software Quality Assurance Engineer

We are recruiting a Senior Software Quality Assurance Engineer to ensure software quality and compliance with FDA, ISO, and IEC standards. You will review requirements, test deliverables, and support audit readiness. Ideal for candidates with significant experience in regulated environments and expertise in software validation and quality.

Skills

• software validation
• software quality review
• fda compliance
• iec 62304
• risk management
• gamp 5
• 21 cfr part 11
• validation documentation
• test plan development
• validation protocols
• risk assessment
• configuration management
• version control
• release traceability
• design review
• code review
• quality review
• defect investigation
• cross-functional collaboration
• change management