Expert Quality Engineer (AI)

TL;DR

Expert Quality Engineer (AI): Ensuring quality and regulatory compliance of AI-powered SaMD products across multiple platforms including mobile, cloud, and edge devices with an accent on software and AI quality processes. Focus on translating standards into actionable requirements, audit readiness, and supporting AI governance and regulatory audits.

Location: Must be based in Portugal, United Kingdom, Spain, Germany, Netherlands, or Ireland with a valid EU visa for Portugal

Salary: €52,500 - €82,500 per year

Company

hirify.global is an AI health company providing care programs and medical devices focused on musculoskeletal, women’s health, and mental health conditions.

What you will do

• Be the QA point of contact for AI and Tech teams to ensure compliant AI-enabled software delivery.
• Translate standards and regulations into clear expectations across the development lifecycle.
• Maintain and review audit-ready evidence for software and AI development.
• Support AI-specific governance, change control, defect management, and third-party component testing.
• Contribute to CAPAs, root cause analysis, and effectiveness checks.
• Participate in internal, supplier, and external audits as the software & AI quality subject matter expert.
• Provide training on software and AI quality and regulatory requirements.

Requirements

• 4-6 years in QARA, Quality, or Compliance supporting software products in regulated environments, preferably SaMD/digital health.
• Experience with engineering artifacts: requirements, tickets, test evidence, release notes, risk controls, and traceability.
• Hands-on knowledge of ISO 13485, IEC 62304, ISO 14971 standards.
• Ability to review V&V evidence and identify gaps in requirements coverage and traceability.
• Strong documentation skills creating usable content for engineers.
• Fluent English required.

Nice to have

• Exposure to AI/ML development concepts and ability to challenge assumptions.
• Awareness of IEC 82304-1, cybersecurity lifecycle, and SBOM/vulnerability management.
• Internal auditor certification.
• Experience with Agile, Jira/Confluence, Git/CI workflows.
• Experience supporting various audits.

Culture & Benefits

• Health, dental, and vision insurance.
• Meal allowance and snacks/beverages.
• Equity shares and remote work allowance.
• Flexible working hours and work from home.
• Discretionary vacation and English classes.