Beschreibung
We are looking for a Project Manager QMS (m/f) in the Medical Industry.Our client wants to establish an electronic document management system. As this system is regulated by various regulatory requirements, it needs to be validated before use. The program includes but is not limited to the determination of user requriements, selection of an appropriate commercially available tool (e.g. MasterControl), creation of the validation documentation, training of users and roll out of the system. The goal is to implement an electronic document management system in MED with a pilot started in Q3 2015.
The project manager role scope is to ensure the overall project management and the different project interactions, to release the document management system on time and on budget.
Expected skills of a candidate :
Background in project management
Good communication skills
Background in Medical Device Quality Management System (QMS)
Knowledge of Document Management Processes (QMS)
Knowledge of Design History File document types
Knowledge of computer systems (tools) (used in medical devices QMS; Examples: CAPA, Electronic Document management System, Complaint Handling, Defect Tracking, Requirements Management, Etc.)
Knowledge of computer systems (tools) validation Preferred
Knowledge of Electronic Document Management Systems Preferred (Mastercontrol would be perfect)
Fluent English
Location: Area of Frankfurt/Main
Start Date: 01. April 2015
Duration: 6 months +
For a full breakdown of the project details and position deliverables please send the latest version of your CV to us. Reference :J097512 Duration :6 months+ Location : Area of Frankfurt Languages : fluent English (+German) emagine GmbH Huber, Nadja T : F :