Expert Quality Engineer

About the Company

Sword Health is a digital health startup focused on AI-powered healthcare solutions.

• Founded by a mix of Engineers and Medical Doctors

• Mission: Shift healthcare from human-first to AI-first, making world-class healthcare accessible anytime, anywhere

• Achievements: 700,000+ members, 10 million AI sessions, 42 clinical studies, 44+ patents, $500M+ funding from top investors.

Job Overview

• Position: Expert Quality Engineer (Software & AI-focused)

• Location: Remote (Portugal or US; must have legal right to work)

• Salary: £52,500 - £82,500/year (base + variable + equity)

• Job Type: Full-time, permanent

Purpose: Ensure quality and regulatory compliance of AI-powered SaMD products, across mobile apps, cloud, edge devices, and AI platforms.

Key Responsibilities

• Serve as QA point of contact for AI & software teams

• Translate standards and regulations (ISO, IEC, etc.) into actionable expectations

• Maintain audit-ready evidence for software/AI development

• Support AI-specific governance, change control, defect management, and third-party components

• Participate in internal and external audits as a subject matter expert

• Provide training to teams on software and AI-specific quality processes

• Contribute to CAPAs, root cause analysis, and investigations

Experience & Skills Required

• 4-6 years in QARA / Quality / Compliance for regulated software products (SaMD/digital health preferred)

• Familiar with ISO 13485, IEC 62304, ISO 14971

• Experience reviewing V&V evidence for software/AI

• Strong documentation and communication skills

• Exposure to AI/ML concepts (datasets, evaluation metrics, drift monitoring)

• Familiarity with IEC 82304-1, cybersecurity lifecycle, SBOM/vulnerability management

• Internal auditor certification

• Agile, Jira/Confluence experience, working alongside Git/CI teams

Eligibility

• Must be based in Portugal with a valid EU visa, or legally able to work in the US

• Remote-first work, flexible schedule, must meet full-time eligibility

Benefits

Portugal: Health, dental, vision insurance, meal allowance, equity shares, remote work allowance, flexible hours, home office, discretionary vacation, snacks, English classes.
US: Health, dental, vision insurance, equity shares, PTO, parental leave, 401(k), remote-first, digital therapist, paid holidays.