About Circadia Health
Circadia Health is a growth-stage healthcare AI company on a mission to prevent avoidable hospitalizations and transform senior-care operations. Our Circadia Intelligence Platform combines:
Contactless sensing that monitors respiration and motion with medical-grade accuracy
Native predictive models that detect 85% of preventable adverse events several days in advance
Enterprise integrations that operationalize predictions directly inside EHR, care-coordination, billing, and compliance workflows
Today, our technology touches 40,000+ post-acute patients daily across skilled-nursing, home-health, and home-care networks. We are backed by leading healthcare and AI investors and headquartered in El Segundo, CA.
Responsibilities
- QMS Architecture: Lead the design, implementation, and roll-out of an ISO 13485-compliant Quality Management System.
- Process Creation: Establish and standardize core quality procedures, including document control, change management, CAPA, nonconformance, and audit readiness.
- Compliance Standards: Ensure organizational alignment with ISO 13485 and prepare the company for FDA Inspections/Notified Body audits.
- Complaint Handling: Establish and execute end-to-end complaint handling processes, root-cause investigations, and medical device reporting (MDR) evaluations.
- CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions.
- Post-Market Surveillance (PMS): Design and maintain the Post-Market Surveillance (PMS) system, generating PMS reports, clinical evaluation updates, and data trending summaries.
- Support execution and maintenance of design control activities across the product lifecycle.
- Maintain Design History File (DHF) documentation for Circadia products.
- Assist with preparation and review of:
- Design inputs and outputs
- Risk management documentation
- Verification and validation documentation
- Design review records
- Track design control deliverables and coordinate documentation across teams.
- Assist in preparation of FDA submission documentation (e.g., 510(k)).
- Support compilation and organization of testing documentation and reports.
- Track submission deliverables and supporting evidence.
- Coordinate with R&D, Engineering, Customer Success, Ops and Clinical teams to collect documentation and evidence.
- Support human factors validation and cybersecurity testing coordination.
- Assist with third-party testing documentation collection.
QMS Building & Implementation
Post-Market Surveillance, Complaints & CAPA
Design Controls & Product Development Support
Regulatory Submission Support
Cross-Functional Collaboration
Qualifications
Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.
Senior-Level Expertise: 5+ years of design quality engineering experience within the medical device or digital health industry.
Startup Track Record: Proven experience in a fast-paced environment where you built processes from scratch rather than executing existing ones, and are comfortable owning ambiguous, evolving work.
QMS Implementation: Direct experience building and implementing an ISO 13485 QMS
Subject Matter Ownership: Deep, hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).
Nice to Have
QMSR Familiarity: Direct experience or working knowledge of the FDA’s updated Quality Management System Regulation (QMSR).
Digital Health / Hardware + Software: Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD), firmware/hardware integration, human factors validation, and cybersecurity.
Regulatory Submissions: Direct involvement in successful FDA submissions or European CE mark technical files.
Certifications: ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Green/Black Belt.
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