Director, SaMD Quality Assurance & QMS Leader

Hippocratic AI; Menlo Park (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

ISO 13485

FDA QMSR

Quality Management System

QA leadership

SOP development

Regulatory audits

Risk management

Agile / DevOps

Clear communication

Education

Bachelor's degree

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

Tools

Jira

GitHub

CI/CD

Job description

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.