Change Control Specialist

Location: Eindhoven, North Brabant Salary: competitive
Sector: Engineering Type: contract

Change Control Specialist

Do you want to work for an international company and work as a Change Control Specialist? For our client Progressive Recruitment is 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 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.

We are looking for

  • 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: Procedural or Technical writing experience, awareness of Project Management Institute standards, understanding of modeling tools and an engineering background.

Practical information

  • Contract: temporary (11 months)
  • Region: Eindhoven

Sthree Holland is acting as an Employment Business in relation to this vacancy.