Quality Engineer I
Core
Ensure product quality, process effectiveness, and regulatory compliance in medical device manufacturing operations.
Role type
Quality Engineer I (Manufacturing)
Builds
Safe, reliable, and compliant dialysis products (HD liquid concentrate, disinfectants)
Domain
Healthcare / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, risk management, validation activities, statistical analysis, project management, change control, complaint handling
Preferred skills
Six Sigma Yellow or Green Belt, familiarity with electronic QMS systems
Technologies
Microsoft Office, electronic QMS systems
Responsibilities
Support and continuously improve the Quality Management System (QMS), investigate non-conformities and drive corrective and preventive actions (CAPA), lead root cause investigations and verify corrective action effectiveness, monitor quality data trends and KPIs, support validation and risk management activities, lead complaint investigations and quality improvement projects
Seniority
Junior to Mid-level, hands-on IC
