Quality Systems Specialist
Core
Supporting, maintaining, and continuously improving the Quality Management System (QMS) for a medical device company, ensuring compliance with global regulations and standards.
Role type
Quality Systems Specialist
Builds
Quality processes and regulatory compliance for the Tablo® Hemodialysis System
Domain
Medical devices / Dialysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) management, document control, change control, nonconformance tracking, CAPA program management, audit preparation and execution, regulatory compliance monitoring, data trend analysis, training program management
Preferred skills
Lead Auditor Certification, Lean Six Sigma training
Technologies
Electronic QMS systems
Responsibilities
Support monitoring and continuous improvement of Quality Management System processes; Collaborate with Engineering, Manufacturing, and Quality teams on quality processes; Support internal and external audit preparation and execution; Monitor and trend Quality Management System nonconformances and quality data; Drive training activities and tracking; Assist with generation, analysis, and presentation of quality metrics; Support the Corrective and Preventive Action (CAPA) program; Support document control activities; Track and assess new or revised external standards and regulatory requirements; Ensure adherence to company procedures and applicable regulatory and quality standards
Seniority
Mid-level, hands-on IC