Director, Quality Assurance SaMD
Lead the Quality Assurance efforts at Hippocratic AI, building a robust Quality Management System for healthcare-focused AI solutions.
Posted by employer 1 day ago
First seen on Joblaze 8 hours ago
Last verified on the company career page 8 hours ago
Skills & Technologies
What you'll build
- Build the Quality Management System
- Implement design controls and software lifecycle
- Own ISO 14971 risk management
- Manage certification body and audits
- Support quality and technical documentation for submissions
Must have
- 10+ years in medical device QA
- 5+ years in SaMD/SiMD
- Built a QMS from zero at a digital health or SaMD startup
- Led an organization to initial ISO 13485 certification
- Hosted or co-hosted an FDA inspection
Nice to have
- Experience with AI/ML-enabled devices
- MDSAP or EU MDR experience
- Familiarity with HIPAA, SOC 2, or ISO 27001
- Advanced degree (MS/PhD)
- ISO 13485 Lead Auditor certification
Requirements
- Experience
- 10+ years
- Education
- Bachelor's degree
Not disclosed in this posting: compensation, work arrangement, visa sponsorship.
Joblaze summary
The Director of Quality Assurance at Hippocratic AI is responsible for establishing and managing the Quality Management System (QMS) to ensure compliance with ISO 13485:2016 and readiness for FDA inspections. This role requires extensive experience in medical device quality assurance, particularly in software as a medical device (SaMD), and a proven track record of building QMS from the ground up. Ideal candidates will have a strong background in regulatory standards and risk management, along with the ability to influence cross-functional teams in a fast-paced environment.
Joblaze insights
- Listed today — first seen on Joblaze November 14, 2026. Last confirmed on Hippocratic AI's careers page November 14, 2026.
Quick facts
- How much experience is required?
- At least 10 years of relevant experience for this Director, Quality Assurance SaMD role.
- What's the tech stack?
- Joblaze extracted these technologies from the posting: 21 CFR Part 11, FDA, IEC 62304, IEC 62366-1, ISO 13485, ISO 14971.
- What seniority level is this role?
- Hippocratic AI targets director candidates for this position.
- Is this full-time or contract?
- Full-time for this Director, Quality Assurance SaMD role at Hippocratic AI.
From the original posting
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.
Standard company text repeated across Hippocratic AI's postings is omitted here.