Quality Engineer 1 (Alajuela, Costa Rica)
Core
Provide statistical support, plan, control, and ensure quality of medical device products, processes, and validations per regulatory standards.
Role type
Quality Engineer (Medical Devices)
Builds
Medical device manufacturing processes and quality systems
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Root cause analysis, CAPA management, Internal auditing, Process improvement, Quality system compliance, Non-conformance management, Training delivery, Microsoft Office, Statistical software
Preferred skills
CQE certification, Six Sigma Green/Black Belt, 1 year in Medical Devices
Technologies
Microsoft Office, Statistical software
Responsibilities
Provide statistical support for sampling plans, dimensional tolerances, and inspection methodologies; Manage and support resolution of product non-conformities; Coordinate continuous improvement processes in manufacturing and inspection; Analyze failures and CAPAs for customer complaints; Ensure compliance with manufacturing and packaging procedures; Participate in internal and external audits as Subject Matter Expert.
Seniority
Junior (Intern)