Director, SaMD Quality Assurance & QMS (FDA Ready)

Hippocratic AI Inc.; Menlo Park (CA); On-site; USD 210,000 - 320,000; Full time

Job summary

Hippocratic AI Inc. seeks a Director of Quality Assurance to design and own the company’s Quality Management System and drive ISO 13485 certification and FDA readiness. This hands-on role reports to leadership and shapes quality culture across engineering, clinical, and product teams.

You will lead gap assessments, implement an eQMS integrated with Jira and CI/CD, and guide audits, CAPA, and regulatory submissions for a health AI platform. Strong regulatory and leadership experience required.

Qualifications

• Bachelor’s degree from an accredited four-year university.
• 10+ years in medical device QA, including 5+ years in SaMD/SiMD.
• Led 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).
• Supported at least one FDA clearance/authorization for a software device (510(k), De Novo, PMA).
• Deep knowledge of ISO 13485, FDA QMSR, IEC 62304, ISO 14971, 21 CFR Part 11, plus cybersecurity guidance.
• Applied design controls in agile, cloud-native, continuous-delivery environments, with an eQMS.

Responsibilities

• Build the QMS: write the Quality Manual, policies, SOPs, and configure/validate an eQMS.
• Design controls and software lifecycle, including AI/ML controls and traceability per IEC 62304.
• Own ISO 14971 risk management including AI hazards.
• Manage audits and FDA readiness, including Stage 1/2 audits and 483 responses.
• Lead core quality processes: CAPA, MDR/vigilance, supplier qualification, document control, training, and management review.
• Support submissions for 510(k), De Novo, and Q-Sub filings.
• Serve as QMS Management Representative and build a quality-focused culture.

Skills

QA leadership

Regulatory affairs

FDA readiness

ISO 13485

Design controls

SOP writing

Agile / cloud-native

Communication

Education

Bachelor’s degree

Engineering / CS / Life Sciences

Job description

Hippocratic AI Inc. seeks a Director of Quality Assurance to design and own the company’s Quality Management System and drive ISO 13485 certification and FDA readiness. This hands-on role reports to leadership and shapes quality culture across engineering, clinical, and product teams.

You will lead gap assessments, implement an eQMS integrated with Jira and CI/CD, and guide audits, CAPA, and regulatory submissions for a health AI platform. Strong regulatory and leadership experience required.