Director, Quality Assurance SaMD

Hippocratic AI | Healthcare AI

8h 41m ago

On-site

Full Time

Lead

United States of America

About the Role

Hippocratic 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.

Why Join Hippocratic AI

Reinvent healthcare with AI that puts safety first. We’re building the world’s first healthcare‑only, safety‑focused LLM — a breakthrough platform designed to transform patient outcomes at a global scale. This is category creation.

Work with the people shaping the future. Hippocratic AI was co‑founded by CEO Munjal Shah and a team of physicians, hospital leaders, AI pioneers, and researchers from institutions like El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA.

Backed by the world’s leading healthcare and AI investors. We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children’s, WellSpan Health, John Doerr, Rick Klausner, and others.

Build alongside the best in healthcare and AI. Join experts who’ve spent their careers improving care, advancing science, and building world‑changing technologies — ensuring our platform is powerful, trusted, and truly transformative.

Equal Opportunity

Please be aware of recruitment scams impersonating Hippocratic AI. All recruiting communication will come from @hippocraticai.com email addresses. We will never request payment or sensitive personal information during the hiring process.

Required Skills

jiragithubci/cd

Required Languages

🇬🇧 English

About the Role

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.

Why Join Hippocratic AI