Quality Engineer - Remedy & Readycare
Core
Establish quality standards, validate processes, and manage supplier quality for medical device manufacturing and product development.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes, validated testing methods, and compliant technical documentation (DMRs, 510K submissions)
Domain
Medical Devices / Manufacturing Quality
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, regulatory compliance (21 CFR 820, ISO13485), supplier qualification, risk management
Preferred skills
Medical device industry experience, advanced Excel skills
Technologies
MS Office Suite, statistical analysis tools
Responsibilities
Design and perform product testing to minimize defects; lead supplier quality programs and corrective actions; ensure compliance with domestic and international regulations; lead investigations of non-conformances and develop preventive actions; generate and maintain Device Master Records and CE technical files.
Seniority
Mid-level, hands-on IC
