Perform change control activities in Novocure systems including, but not limited to, SAP Master Data and Mastercontrol.
Create, maintain, and retire e-Route Cards in SAP S4 Hana in support of Quality Control, Service, and Operations in global Operating Centers
Assures locally procured and distributed materials for individual Operating Centers are subject to appropriate specification and document control
Designs and implements new processes and process improvements, particularly in relation to change management and SAP QM/eRoute Card
Participates in internal audits and regulatory authority inspections, as required
Participate in Corrective and Preventive Actions (CAPA), as required
Reviews and provides input into operational QA strategies, and executes for results. Ensures approaches are innovative, industry leading, and meeting the needs of Novocure patients and related Enterprise business strategies
Works with the Change and Configuration Manager, the QA team, and the IT team organization to deliver against strategic goals and improvement plans
requirements-expected :
At least 2+ year experience in SAP/QM
Demonstrated experience writing, evaluating and improving process procedures
Proven ability to manage projects and influence teams of significant scope and complexity, while
meeting all deliverables and timelines
Outstanding written and oral communication skills in English
Familiarity with Change Control and Quality Risk Management and process validation
Familiarity with Quality System Regulation, Medical Device Directive / Medical Device Regulation, ISO 13485 / FDA is a plus
