Quality System Manager
Core
Managing and controlling document control activities and the Quality Management System (QMS) for manufacturing plants, ensuring compliance with ISO13485 and MDSAP standards.
Role type
Quality System Manager
Builds
Quality Management System (ISO13485 and MDSAP) for MXC and MDC plants
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO13485 standard knowledge, MDSAP knowledge, internal/external audit execution, customer complaint investigation, root cause analysis, CAPA coordination, statistical trend analysis, document control management, SAP QA module management, EtQ Reliance system administration
Preferred skills
Clean room monitoring, quality scorecard management, process improvement project leadership
Technologies
EtQ Reliance, SAP, Packdraw, Mpower, Munintra, AS400, Microsoft Office
Responsibilities
Manage and control document control activities through EtQ Reliance; Perform internal/external audits across business areas; Coordinate customer complaints investigations and root cause analysis; Lead and support quality process improvement projects/CAPA; Monitor clean room processes and prepare results reports; Generate and analyze trend reports for QA management.
Seniority
Mid-to-Senior level (5-10 years experience)