Project Quality Engineer
Drive quality, AI governance, regulatory compliance, risk management, and lifecycle processes for AI-enabled healthcare products.
Who Is This Role For?
This opportunity is best suited for a quality, regulatory, or medical-device professional who can connect established Quality Management Systems with AI governance, AI risk management, and the lifecycle requirements of AI-enabled healthcare products.
Medical Device Quality Professional
Experienced in medical-device quality systems, product risk management, software validation, and regulatory documentation.
AI Governance Specialist
Understands AI lifecycle management, governance, risk assessment, validation, monitoring, and change management.
Quality & AI Bridge
Can translate AI development activities into quality, regulatory, documentation, audit, and compliance requirements.
Audit-Ready Quality Thinker
Comfortable reviewing AI evidence, technical documentation, risk assessments, compliance gaps, and release readiness.
Where Quality Engineering Meets AI Governance
The role sits at the intersection of Quality Engineering, Risk Management, Regulatory Compliance, Software Lifecycle Management, and Artificial Intelligence.
Core Mission
Ensure AI-enabled healthcare products are developed, validated, documented, monitored, and maintained in alignment with quality systems, regulatory expectations, AI governance principles, and organizational standards.
What You Will Do
Quality Status & Data Analysis
Analyze and collect quality data and provide accurate, documented information regarding project quality status.
Quality Verification & Release
Verify quality-related development results against the Quality Management Plan and support release authorization for medical devices.
Regulatory Compliance
Validate compliance with applicable ISO standards and regulations, including European Medical Device Regulation and US FDA requirements.
Technical Documentation
Assess the completeness of Design History Files, Device Master Records, technical files, and related quality documentation.
AI Governance & Lifecycle
Provide process expertise for AI-enabled products and assess governance, risk management, lifecycle controls, and effectiveness.
Audit & Compliance Readiness
Review AI-related documentation and evidence supporting product releases, regulatory submissions, audits, and technical file updates.
Risk & Corrective Action
Review AI-related risks, performance issues, compliance gaps, and support appropriate corrective and preventive actions.
Cross-Functional Alignment
Facilitate alignment between AI development activities, quality processes, regulatory expectations, and organizational requirements.
Experience That Matters
Risk Management
Product risk management and non-product software validation processes for medical devices.
Technical Files
Creation and maintenance of technical files and Summary Technical Documentation (STED).
Medical Software
Medical-device development, software validation, and software engineering best practices.
Agile Methods
Experience working with Agile methods and TIR45-based development environments.
AI Quality Across the Product Lifecycle
The role supports AI-enabled products from data and development through validation, deployment, monitoring, and change management.
Data
Data management and quality
Development
AI development and requirements
Validation
AI validation and risk assessment
Deployment
Release and compliance evidence
Monitoring
Performance and lifecycle controls
Change
Continuous improvement and governance
Key Quality & AI Standards
Regulatory Knowledge
European Medical Device Regulation (MDR) • US FDA Quality System Requirements (QSR) • AI governance • AI risk management • Global regulatory expectations for AI-enabled healthcare products
Skills & Knowledge Areas
Build Trustworthy AI for Healthcare
Bring together quality engineering, AI governance, regulatory compliance, and risk management to help shape safer and more reliable AI-enabled healthcare products.
Apply Now ↗