Sword Health is shifting healthcare from human-first to AI-first through its AI Care platform, making world-class healthcare available anytime, anywhere, while significantly reducing costs for payers, self-insured employers, national health systems, and other healthcare organizations. Sword began by reinventing pain care with AI at its core, and has since expanded into women’s health, movement health, and more recently mental health. Since 2020, more than 700,000 members across three continents have completed 10 million AI sessions, helping Sword's 1,000+ enterprise clients avoid over $1 billion in unnecessary healthcare costs. Backed by 42 clinical studies and over 44 patents, Sword Health has raised more than $500 million from leading investors, including Khosla Ventures, General Catalyst, Transformation Capital, and Founders Fund. Learn more at www.swordhealth.com.As part of our ongoing commitment to excellence, we are seeking a talented and detail-oriented Expert Quality Engineer (Software&AI-focused). You will play a crucial role in ensuring the quality and regulatory compliance of our AI-powered SaMD products. You will collaborate with cross-functional teams, including software development, regulatory affairs, and quality assurance, to uphold the highest standards of safety and effectiveness. You will apply your core skills across a range of deployment platforms such as mobile applications, cloud services, edge devices and AI platforms. You will have an opportunity to work across a variety of therapeutic areas and operating room safety and efficiency.
What you’ll be doing:Be the QA point of contact for our AI and Tech teams, helping them ship AI-enabled software that is compliant without slowing delivery.Translate standards and regulations into clear, usable expectations across the development lifecycle (templates, checklists, review gates).Maintain and review audit-ready evidence for software/AI developmentSupport AI specific governanceSupport change control, defect management, and SOUP/third-party components with risk-based documentation and testing expectations.Contribute to CAPAs and investigations: help structure root cause analysis, define actions, and ensure effectiveness checks are meaningful.Participate in internal and supplier audits, support teams in preparation for external audits, and act as the software & AI subject matter expert during audits and inspections from Competent Authorities or Notified Bodies.Provide training to internal teams on SW and AI-specific quality and regulatory requirements. Collaborate effectively with cross-functional teams and serve as the subject matter expert on software & AI quality processes and compliance.
What you need to have:4-6 years in QARA / Quality / Compliance supporting software products in a regulated or quality-driven environment (SaMD/digital health strongly preferred).You work comfortably 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.You review V&V evidence and spot gaps: requirements coverage, test rationale, pass/fail clarity, and traceability completeness.You write clearly and structure documentation well: you create content engineers will actually use.Fluent in English.Exposure to AI/ML development concepts (datasets, splits, evaluation metrics, drift/monitoring basics) to be able to challenge assumptions.Awareness of IEC 82304-1, cybersecurity lifecycle expectations (e.g., IEC 81001-5-1), SBOM/vulnerability management concepts.Internal auditor certification.Experience with Agile, Jira/Confluence, and working alongside teams using Git/CI (no coding required).Experience supporting audits (internal, supplier, Notified Body, or regulatory).
Portugal - Sword Benefits & Perks:• Health, dental and vision insurance• Meal allowance• Equity shares• Remote work allowance• Flexible working hours• Work from home• Discretionary vacation• Snacks and beverages• English classNote: Please note that this position does not offer relocation assistance. Candidates must possess a valid EU visa and be based in Portugal.Sword Health complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.US - Sword Benefits & Perks: • Comprehensive health, dental and vision insurance*• Equity shares*• Discretionary PTO plan*• Parental leave*• 401(k)• Flexible working hours• Remote-first company• Paid company holidays• Free digital therapist for you and your family*Eligibility: Full-time employees regularly working 25+ hours per weekPortugal - Sword Benefits & Perks:• Health, dental and vision insurance• Meal allowance• Equity shares• Remote work allowance• Flexible working hours• Work from home• Discretionary vacation• Snacks and beverages• English class*US Applicants Only: Applicants must have a legal right to work in the United States, and immigration or work visa sponsorship will not be provided.*Please note that this position does not offer relocation assistance. If in Portugal, candidates must possess a valid EU visa and be based in Portugal.Sword Health complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.