Own software design quality across the product lifecycle, including design controls, risk management, change control, release readiness, and algorithm lifecycle oversight. Manage complaint investigations, reportability assessments, post-market surveillance, CAPAs, QMS maintenance, regulatory submissions, and FDA interactions.
The Clinical Quality Consultant will perform clinical case reviews on sepsis alerts to ensure product quality and regulatory compliance. They will also manage caseloads, improve review processes, and collaborate with technical teams to investigate product behavior.
You will design and implement data integration pipelines to connect complex EHR systems with the Bayesian platform to provide real-time clinical insights. Additionally, you will manage production deployments, troubleshoot data issues, and develop automation tooling to improve integration efficiency.
You will build and configure full-stack integrations between the Bayesian platform and complex Electronic Health Record (EHR) systems to deliver real-time clinical insights. Additionally, you will lead deployment processes, perform integration testing, and develop automation tooling to improve engineering efficiency.
You will design and maintain scalable, fault-tolerant cloud infrastructure while building CI/CD pipelines to support software engineers and data scientists. Additionally, you will implement security best practices and architect an internal AI Ops platform to manage AI/ML agents.
