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Senior Document Control Specialist

  • Lokatie: Eindhoven, Noord-Brabant

For one of our clients we are looking for a Senior Document Control Specialist.
 
Your challenge
We are looking for an enthusiastic contingent worker in the area of Change, Document and Record control with experience in Business Quality Management Systems (ISO 9001 / ISO 13485) and FDA (21CFR) regulations within an international environment?
 
Your responsibilities
·         Leads and supports lower level Document Control Specialists.
·         Effective (local) Business Process Expert role for Document Control processes. 
·         Establishes Document & Record support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
·         Leads and supports (global) authors of controlled documents to be lean, well accessible, easy to maintain and according to the agreed look and feel.
·         Effective (local) Business Process Ownership/Expert role for Document Control processes and tools in scope
·         Establish and manage proper document review processes
·         Ensures availability/publishing of controlled documents
·         Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
 
Your team
You will be part of the Center of Excellence – Controlled Documented Information (CoE CDI) team existing of 10 persons dealing with activities like Quality Management, System Validation, Training, CAPA, Management Review and Change, Document & Record Control.
 
Our offer
We welcome you to a challenging, innovative environment in Eindhoven with great opportunities for you to explore. The offer will be based on a temporary contract (1 fte) till end of 2018.
 
We are looking for
Our ideal candidate has the following profile criteria:
·         BA/BS degree.
·         CMII certification (or other equivalent configuration management certification) preferred.
·         6 Sigma/ LEAN certification preferred.
·         Minimum of 6 years of related experience in change control and or document control field
·         Familiarity with Document Management System tools
·         Experience running effective process improvement projects
·         Knowledge of Applicable regulations (Quality System Regulations) and regulatory requirements
·         Strong focus on customer service
·         Preferred Qualifications:
Engineering background.
Procedural or Technical writing experience.
Understanding of modeling tools.
·         Awareness of Project Management Institute standards.