Bayesian Health

QA Engineer

• Partner with engineering and data science across the full software lifecycle, including requirements, architecture review, software risk analysis, verification and validation, traceability, and release readiness
• Maintain the design history file and risk management file in accordance with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR) design controls
• Assess software and model changes for regulatory impact and determine whether a letter-to-file or new submission applies
• Drive changes through the quality management system
• Maintain the risk file and support post-market performance monitoring of deployed algorithms
• Support complaint intake, triage, investigation, and closure
• Prepare MDR reportability assessments under 21 CFR 803 for review and approval
• Trend complaints and field data
• Lead nonconformance reports and CAPAs when patterns emerge
• Ensure feedback from implementation and clinical teams reaches the quality system
• Maintain and update quality procedures, document control, training records, and compliance evidence
• Support internal audits and prepare management review inputs
• Manage supplier controls for EHR, cloud, and subcontractor relationships
• Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans
• Respond to FDA questions and support FDA inspections
• Monitor FDA guidance on AI/ML-enabled devices, cybersecurity under Section 524B, and quality system expectations
• Translate emerging regulatory requirements into changes to procedures and product requirements
• Embed compliance into product, engineering, and commercial workflows
• Communicate quality metrics and risk to technical and non-technical audiences, including executives
• Work directly with engineering, data science, clinical, and implementation teams under the direction of the Head of Quality and Regulatory

Senior Design Quality Engineer

Consultant

• Perform clinical case reviews on sepsis alerts by working the encounter record, establishing the clinical timeline, determining whether the alert behaved as designed, and producing an internal case review with cited evidence and a recommended next action
• Build and apply knowledge of how the product generates, suppresses, and delivers flags, including EHR data driving it
• Review AI-assisted triage and classification, including investigation and complaint classification, ticket creation, and draft acknowledgements, and correct unsupported outputs
• Write responses to clinicians and clinical informatics teams while protecting patient privacy and avoiding clinical direction
• Route issues to data science, engineering, implementation, or clinical teams and drive tickets through closure
• Send close-out communications and close resolved tickets
• Manage a concurrent caseload against response commitments; track status, prioritize by clinical and client risk, and keep the queue current
• Identify recurring patterns such as mapping failures, interface latency, and suppression gaps; quantify frequency and raise issues with owning teams
• Create and improve case review templates, evidence standards, response language, triage rules, and escalation paths
• Document processes so reviewers reach consistent conclusions from the same facts
• Support product complaint handling by documenting complaints and assembling clinical evidence
• Once trained, contribute to disposition of possible anomalies in the regulated-device release process

Senior Design Quality Engineer

Clinical Quality Consultant