Quality Engineer - Advanced Wound Care
Core
Independently set quality standards, develop testing methods, and manage vendor quality for advanced wound care medical devices.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation for wound care products.
Domain
Medical Devices / Wound Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control (SPC), experimental design, CAPA management, supplier qualification, regulatory compliance (21 CFR 820, ISO13485), MS Office Suite
Preferred skills
Medical device industry experience, advanced Excel skills
Technologies
MS Office Suite, SPC tools
Responsibilities
Manage process control and validation methods; design experiments to analyze variation; lead supplier quality programs and investigations; build Device Master Records and regulatory submissions; ensure compliance with domestic and international regulations.
Seniority
Mid-level, hands-on IC
