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Document Control Specialist

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The company

Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands. The company is an international company and their Medical Devices department is located in Eindhoven.

Role description

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.

Responsibilities

 Leads and supports lower level Document Control Specialists.
 Effective (local) Business Process Expert role for Document Control processes and tools in scope.
 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.

Requirements

 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:
o Engineering background.
o Procedural or Technical writing experience.
o Understanding of modeling tools.
o Awareness of Project Management Institute standards.



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SIRE Life Sciences®

Ref. number: 39327
Listed by: SIRE Life Sciences®
Listed on: 16-02-2018
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 6 - 10 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Biostatistics & Data Management

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Contact

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