Expert Quality Engineer
Location:Portugal
Languages:English
Seniority level:Senior, 4-6 years
Experience:4-6 years
Skills:
Software DevelopmentAgileArtificial IntelligenceMachine LearningQAJiraAPI testingManual testingRegression testingCI/CDDocumentationProblem SolvingAttention to detailComplianceConfluenceCross-functional collaborationRisk Management
Requirements:
4-6 years in QARA / Quality / Compliance supporting software products in a regulated or quality-driven environment (SaMD/digital health strongly preferred). Comfortable with engineering artifacts and workflows: requirements, tickets, test evidence, release notes, risk controls, and traceability. Hands-on experience with the requirements of: ISO 13485, IEC 62304, ISO 14971. Review V&V evidence and spot gaps. Write clearly and structure documentation well. Fluent in English.
Responsibilities:
Be the QA point of contact for AI and Tech teams. Translate standards and regulations into clear, usable expectations. Maintain and review audit-ready evidence for software/AI development. Support AI specific governance. Support change control, defect management, and SOUP/third-party components. Contribute to CAPAs and investigations. Participate in internal and supplier audits. Provide training to internal teams on SW and AI-specific quality and regulatory requirements. Collaborate effectively with cross-functional teams.
