About the RoleHippocratic AI builds safety-focused generative AI agents for healthcare. We're hiring our first
Director, Quality Assurance to build and own our Quality Management System (QMS), get us to
ISO 13485:2016 certification, and make us ready for an
FDA inspection under the QMSR (21 CFR Part 820). This is a hands-on builder role in a fast-moving AI engineering organization.
Key Responsibilities- Build the QMS: Run the gap assessment and certification roadmap. Write the Quality Manual, policies, and SOPs. Select, configure, and validate an eQMS, and integrate it with Jira, GitHub, and CI/CD so compliance comes out of normal engineering work.
- Design controls and software lifecycle: Implement design controls, Design History Files, and traceability per IEC 62304, including AI/ML controls for model versioning, dataset management, and change control under PCCP and GMLP principles.
- Risk management: Own ISO 14971 risk management, including AI-specific hazards (hallucination, bias, drift, failure to escalate), and integrate cybersecurity risk per FDA Section 524B.
- Audits and FDA readiness: Manage the certification body and the Stage 1 and Stage 2 audits. Run internal audits and mock FDA inspections. Host regulatory inspections and own responses to 483s and nonconformities.
- Core quality processes: Own CAPA, complaint handling, MDR/vigilance (Parts 803/806), post-market surveillance, supplier qualification (including cloud and LLM vendors), document control, training, and management review.
- Submissions support: Make sure quality and technical documentation are ready for 510(k), De Novo, and Q-Sub filings.
- Leadership: Serve as QMS Management Representative. Build the quality team and a pragmatic quality culture across engineering, clinical, and product.
Required Qualifications- Bachelor's degree from an accredited four-year university.
- 10+ years in medical device QA, including 5+ years in SaMD/SiMD.
- Has personally built a QMS from zero at a digital health or SaMD startup (under ~300 employees), not only maintained an existing system.
- Led an organization to initial ISO 13485 certification as the accountable quality lead.
- Has hosted or co-hosted an FDA inspection (or Notified Body/MDSAP audit) for a software device.
- Has supported at least one FDA clearance or authorization for a software device (510(k), De Novo, or PMA).
- Deep knowledge of ISO 13485, FDA QMSR, IEC 62304, ISO 14971, IEC 62366-1, and 21 CFR Part 11, plus FDA software, CDS, CSA, and cybersecurity guidance.
- Has applied design controls in agile, cloud-native, continuous-delivery environments, and has implemented an eQMS.
- Writes clear, auditable SOPs and influences engineering and executive leaders without slowing delivery.
- Bachelor's degree in engineering, computer science, life sciences, or a related field.
Preferred Qualifications- Experience with AI/ML-enabled devices (PCCPs, model lifecycle controls) or conversational, CDS, or patient-facing digital health products.
- MDSAP or EU MDR experience. Familiarity with HIPAA, SOC 2, or ISO 27001.
- Advanced degree (MS/PhD), ASQ CQA/CQE/CMQ-OE, ISO 13485 Lead Auditor, or RAC certification.
