About the role

What you’ll do

• Serve as software validation subject matter expert for an Agile team
• Translate business workflows, acceptance criteria, regulatory expectations, and risks into testable requirements and validation coverage
• Support compliant software delivery, testing, traceability, and continuous improvement
• Evaluate user stories, defects, acceptance criteria, and test evidence for adequate, traceable, and objective validation coverage
• Provide clear guidance on blood bank workflow and user needs
• Manage multiple priorities and adapt to changing sprint commitments

What you’ll need

• Bachelor's degree from an accredited college or university
• Five years of experience in regulated quality assurance, blood bank environment, software testing, business analysis, validation, or equivalent
• Ability to analyze and document complex business processes, user workflows, risks, and system behavior
• Working knowledge of software verification and validation practices, traceability, risk-based testing, defect management, change impact assessment, and objective evidence in a regulated environment
• Strong analytical, facilitation, collaboration, communication, and problem-solving skills
• Ability to explain technical, regulatory, and workflow concepts in clear, non-technical terms

Original job description