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Expert Quality Engineer
hace 3 semanas
Sword Health is an AI health company that provides care programs for multiple conditions, from musculoskeletal, to women's health, to mental health. Our medical devices serve an essential role in ensuring care quality and safety. 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 Do (Quality For AI/SaMD)
- 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.
Required Qualifications And Experience
- 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
Nice to have
- Exposure to AI/ML development concepts (datasets, splits, evaluation metrics, drift/monitoring basics) to be able to challenge assumptions
- Awareness of IEC , cybersecurity lifecycle expectations (e.g., IEC , 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)
What Success Looks Like In This Role
- Development teams know exactly what evidence is needed for each release and produce it naturally as part of delivery
- Traceability, risk controls, and validation evidence are complete and defendable
- AI changes are handled with clear impact assessments and the right level of re-validation
- 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.
