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Boston Scientific4 days ago

Senior Software Quality Engineer

On-site · Galway, Connacht, Ireland

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Senior Software Quality Engineer responsible for developing, applying and maintaining standards for software quality methods, processes and procedures to meet regulatory requirements. Leads software validation activities across Waterfall and Agile environments, guides project teams on validation strategies, and ensures compliance. Performs independent reviews of deliverables, coaches less experienced colleagues, and contributes to SOP development and continuous improvement. Requires expertise in software validation, regulatory standards, and collaboration across management and cross-functional teams. Demonstrates ability to lead validation initiatives, communicate concepts effectively, and manage multiple priorities in a cross-functional setting.

Required Qualifications

  • Bachelor's degree in Engineering or related field
  • 6 years of related experience with 3+ years in Software Quality and validation
  • Working knowledge of 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
  • Some experience with Agile software development and validation methodologies
  • Experience with QA tools (JIRA, Xray, qTest)
  • Experience with AI applications
  • Strong written and verbal communication skills
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Boston Scientific

Senior Software Quality Engineer

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