> Markdown version of [/jobs/ext/4150843-design-quality-engineer](https://www.wearedevelopers.com/jobs/ext/4150843-design-quality-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Quality Engineer - **Company:** Bayesian Health, Inc. - **Location:** United States (Remote available) - **Experience:** Expert - **Salary:** $142,768.0 - $161,901.0 - **Contract:** Permanent contract - **Skills:** Cerner, Artificial Intelligence, JIRA, Automation of Tests, Software Quality, Document Management Systems, Software Engineering, System Testing, Fast Healthcare Interoperability Resources, Performance Monitor, Real Time Data - **Published:** October 2, 2026 - **Apply:** https://startup.jobs/senior-design-quality-engineer-bayesian-health-inc-10264949 ## About the Role * A BS in Computer Science, Systems Engineering, Biomedical Engineering, or a related technical field, or equivalent practical experience * 5+ years in software quality, design quality engineering, or regulatory work for software medical devices under ISO 13485 and IEC 62304, including hands-on ownership of design controls and ISO 14971 risk management files * Experience with complaint handling and adverse event reportability decisions under 21 CFR 803 and 21 CFR 820 (QSR or QMSR), including complaint investigation, trending, and CAPA * A track record of writing, maintaining, and improving QMS procedures, document control, and change management in a regulated software environment * The ability to read code, logs, and automated test results well enough to investigate a software issue independently, and comfort working with engineers in a cloud-based SaaS environment * Working knowledge of FDA premarket cybersecurity expectations under Section 524B, including threat modeling, SBOM management, and vulnerability handling * Excellent written communication. You produce audit-ready records and can explain regulatory concepts to engineers, clinicians, and executives without losing precision * A high level of drive, a process-fixer mindset rather than a process-follower one, and the ability to learn fast and communicate clearly * Current, unrestricted authorization to work in the United States Nice to Haves * Experience with AI/ML-enabled medical devices, including algorithm change control, Predetermined Change Control Plans, model performance monitoring, and FDA AI/ML guidance * Direct experience preparing 510(k)s or Q-Submissions and corresponding with FDA reviewers * Familiarity with EHR-integrated software such as Epic or Oracle Health, SMART on FHIR, or CDS Hooks, and the security and quality due diligence enterprise health systems perform on vendors * Experience supporting a lead or primary contact in FDA inspections, ISO 13485 certification audits, or customer audits * Experience with eQMS platforms, Jira-based defect tracking, and computerized system validation * An ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification ## Description Bayesian ships FDA-cleared, AI clinical decision support software directly into Epic and Oracle Health workflows at health systems across the country. Every release, every model update, and every clinician report that an alert didn't behave as expected runs through a quality and regulatory system that has to be as rigorous as the software itself. You will help drive that system. This role intentionally wears multiple hats. We're a small company, and we need one person who can do several things well: engineer quality into the software as it's built, handle the post-market side once it's in production, and keep the quality management system and our regulatory obligations current as we scale. You'll work directly with engineering, data science, clinical, and implementation teams, with support from company leadership, while under the direction of the Head of Quality and Regulatory. You're the engineer in the room on quality questions. When a hospital reports that the model flagged a patient late, you decide whether it's a complaint, whether it's reportable, and what changed in the software or the data. You can read the code, the logs, and the test evidence to find out., Assess software and model changes for regulatory impact, determining whether a letter-to-file or a new submission applies, and drive the change through the quality management system. Maintain the risk file and support post-market performance monitoring of the deployed algorithm., Support complaint intake, triage, investigation, and closure. Prepare MDR reportability assessments under 21 CFR 803 for review and approval, trend complaints and field data, and lead nonconformance reports and CAPAs when patterns emerge. Work closely with the implementation and clinical teams, who hear from clients first, to make sure feedback reaches the quality system. QMS Improvement & Maintenance Maintain and update quality procedures, document control, training records, and compliance evidence as the company grows. Support internal audits, prepare management review inputs, and manage supplier controls for EHR, cloud, and subcontractor relationships. Regulatory Interactions & Submissions Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans. Respond to FDA questions and support the team during FDA inspections. Regulatory Intelligence Monitor FDA guidance on AI/ML-enabled devices, cybersecurity under Section 524B, and quality system expectations. Translate emerging requirements into concrete changes to procedures and product requirements.