Configuration Engineer (SAP QM) - Quality Operations
technologies-expected :
- SAP
responsibilities :
- 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
offered :
- Performance related bonus
- Life Insurance
- Free fruit & cookies delivered for office staff
- Multisport card
- Private Medical care
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