Expert Quality Engineer

SWORD Health; Deutschland; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Meal allowance

Equity shares

Remote work allowance

Flexible working hours

Work from home

Discretionary vacation

Snacks and beverages

English class

Job summary

Sword Health is seeking an Expert Quality Engineer to ensure the quality and regulatory compliance of AI-powered SaMD products across mobile, cloud, edge devices and AI platforms. You will collaborate with software, regulatory affairs and QA teams to uphold safety and effectiveness.

English fluency and regulatory know-how are essential. You will translate standards into practical requirements, maintain audit-ready evidence, and support governance, risk management, and external audits in a

Qualifications

• 4-6 years in QARA / Quality / Compliance supporting software products in a regulated or quality-driven environment (SaMD/digital health strongly preferred).
• Fluent in English.
• Exposure to AI/ML development concepts (datasets, splits, evaluation metrics, drift/monitoring basics).
• Awareness of IEC 82304-1, cybersecurity lifecycle expectations (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).

Responsibilities

• 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 development.
• Support AI specific governance.
• Support change control, defect management, and SOUP/third-party components with risk-based documentation and testing expectations.
• Contribute to CAPAs and investigations: structure root cause analysis, define actions, ensure effectiveness checks are meaningful.
• Participate in internal and supplier audits, support teams in preparation for external audits, act as the software & AI SME during audits and inspections from Competent Authorities or Notified Bodies.
• Provide training to internal teams on SW and AI-specific quality and regulatory requirements.

Skills

QARA / Quality / Compliance

AI/ML basics

Agile

Jira/Confluence

Git/CI

Regulatory awareness

Tools

Jira/Confluence

Git/CI

Job description

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.

Expert Quality Engineer (Software & AI-focused)

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 development
• Support AI specific governance
• Support 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).

Compensation

*This range includes base, variable and equity

These compensation bands are just the starting point. Once someone joins and proves they’re outlier talent, we adjust quickly to ensure their compensation aligns with their impact.

Our job titles may span more than one career level. Actual pay is determined by skills, qualifications, experience, location, market demand, and other factors. Compensation details listed in this posting reflect the base salary and any potential variable, bonus or sales incentives, and the Company’s estimation of the value of private company stock options, if applicable. The pay range is subject to change, future value of company stock options is not guaranteed, and compensation may be modified in the future. In addition to our total compensation, Sword offers a number of benefits as listed below.

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 class

Note: Please note that this position does not offer relocation assistance.

Candidates must possess a valid EU visa and be based in Portugal.

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 week

*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.

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 class

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.

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.