Quality Professional
Core
Analyze quality standards for components, materials, or services; apply measures, sampling methods, and testing methodologies to ensure quality compliance in medical diagnostics.
Role type
Quality Professional (Medical Devices/Diagnostics)
Builds
Safe and effective diagnostic products and components
Domain
Healthcare / Medical Diagnostics / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system compliance, Risk Management (FMEA), Design Verification/Validation, Documentation review, Inspection and validation of components, Vendor liaison, Data analysis and reporting
Preferred skills
FDA regulations, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, 21 CFR Part 11
Technologies
FMEA, 21 CFR Part 11
Responsibilities
Participate in design change control activities including input, risk management, verification, and validation; Develop and modify Risk Management Files; Review documentation for accuracy and compliance; Coordinate quality decisions between engineering and quality groups; Conduct inspection and verification of components used in development processes; Liaise with external vendors
Seniority
Mid-level, hands-on IC
