Quality Engineer - Advanced Wound Care
Core
Independently set quality standards, develop testing methods, and ensure compliance with regulations 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, risk management, CAPA development, supplier quality management, 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 development of process control and validation methods; Design experiments to analyze product variation; Lead supplier qualifications and corrective actions; Build Device Master Records and CE technical files; Coordinate product testing with internal and external laboratories; Lead investigations of non-conformances and out-of-specification results.
Seniority
Mid-level, hands-on IC