Quality Engineer
Core
Ensures quality standards and compliance with FDA and ISO 13485 requirements for medical device manufacturing, managing validation, audits, and continuous improvement.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes and quality systems for dental implants and prosthetics
Domain
Medical Devices / Dental Implants
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485 compliance, FDA regulations, CAPA investigations, Gauge R&R studies, measurement system analysis, risk management, data analysis for predictive quality, supplier qualification, root cause analysis (5 Whys, Fishbone, DMAIC)
Preferred skills
CNC milling, precision manufacturing, dental lab operations, glass/ceramics/zirconia materials, Minitab statistical software
Technologies
Microsoft Office Suite, Minitab
Responsibilities
Develop and maintain Quality Assurance Management System and SOPs; Lead resolution of non-conformance reports and customer complaints; Oversee production quality control via internal audits; Support supplier audits and qualification; Perform advanced data analysis to detect anomalies; Translate risk management insights into process controls.
Seniority
Mid-level, hands-on IC