Expert Quality Engineer
Sword Health
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See open jobs at Sword Health.See open jobs similar to "Expert Quality Engineer" General Catalyst.Quality Assurance
Remote
EUR 52,500-82,500 / year + Equity
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).
52500 - 82500 EUR a year
This job is no longer accepting applications
See open jobs at Sword Health.See open jobs similar to "Expert Quality Engineer" General Catalyst.