Director, Quality Assurance SaMD

Hippocratic AI; Menlo Park (CA); Vor Ort; USD 250.000 - 350.000; Vollzeit

Zusammenfassung

Hippocratic AI in Menlo Park, CA seeks a Director, Quality Assurance to build and own the QMS, aiming for ISO 13485:2016 certification and FDA readiness under QMSR. This hands‑on leadership role integrates with engineering, clinical, and product teams to ensure safe, compliant AI medical devices.

The role requires 10+ years in medical device QA (5+ in SaMD/SiMD), proven QMS build from scratch, and successful FDA interactions. Strong leadership, SOPs, and regulatory knowledge are essential.

Qualifikationen

• Bachelor’s degree from an accredited four‑year university.
• 10+ years in medical device QA, including 5+ years in SaMD/SiMD.
• Built a QMS from zero at a digital health or SaMD startup (under ~300 employees).
• Led an organization to initial ISO 13485 certification as the accountable quality lead.
• Hosted or co‑hosted an FDA inspection (or Notified Body/MDSAP audit) for a software device.
• 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; FDA software, CDS, CSA, cybersecurity guidance.
• Applied design controls in agile, cloud‑native, continuous‑delivery environments, and implemented an eQMS.
• Wrote clear, auditable SOPs and influence engineering and executive leaders without slowing delivery.
• Bachelor's degree in engineering, computer science, life sciences, or related field.

Aufgaben

• Build the QMS: run gap assessment and certification roadmap; write Quality Manual, policies, and SOPs.
• Select, configure, and validate an eQMS; integrate with Jira, GitHub, and CI/CD.
• Design controls and software lifecycle per IEC 62304 with AI/ML controls.
• Own ISO 14971 risk management including AI hazards; integrate cybersecurity risk per FDA 524B.
• Manage certification body and Stage 1/2 audits; host inspections and respond to 483s.
• Own CAPA, complaint handling, MDR/vigilance, post‑market surveillance, supplier qualification.
• Submissions support for 510(k), De Novo, and Q-Sub filings.
• Lead as QMS Management Representative and build a quality team.

Kenntnisse

ISO 13485

FDA QMSR

Quality Management System

QA leadership

SOP development

Regulatory audits

Risk management

Agile / DevOps

Clear communication

Ausbildung

Bachelor's degree

Advanced degree or certifications (MS/PhD, ASQ CQE/CMQ-OE, RAC)

Tools

Jira

GitHub

CI/CD

Jobbeschreibung

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 escape), 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 $126 M Series C at a $3.5 B valuation, led by Avenir Growth, bringing total funding to $404 M 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

Hippocratic AI is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic information, military or veteran status, or any other characteristic protected by applicable law. We are committed to building a team that reflects the patients we serve. We actively encourage applications from candidates of all backgrounds. If you require accommodations during the hiring process, please contact [e-mail].

Note: 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.