Document and Change Control expert
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
This international market leader within the Medical Devices industry is continuously growing. They are one of the leaders in technological developments and innovation. They are active within a broad range of industries, and focus on technology and innovation.
ROLE DESCRIPTION
In your role as Document control specialist you are responsible for controlling the documentation and applying the changing in the documentation related to the Quality Management System. You will become part of the quality and regulatory team consisting of 10 people in total. On an daily basis you are involved with the Quality Management System, Corrective Actions, Validation Management and controlling the related documentation. You assist in the improvement and efficiency of existing processes. This project is set for almost a year and can possibly be extended.
RESPONSIBILITIES
Your main responsibility involves the controlling and monitoring of documentation related to the QMS. Furthermore, you must guarantee that the authors of the controlled documents are lean, well organised and easily accessed. Further responsibilities involve:
• Supporting and guiding your team of document control specialists
• Controlling and creating effective processes in relation to document control
• Guaranteeing and defining lean quality system documents and records
• Establishment and management of review procedures for all documentation
• Assistance in execution of CAPA’s, Change Management and Validation Management
• Guiding the team regarding the Quality Management System
REQUIREMENTS
• Bachelor in Engineering
• Minimum of 6 years of experience in the Medical Devices industry
• Related experience with document control and change control in the Medical Device Field
• Experience with LEAN Six Sigma procedures and tools
• Excellent knowledge ISO 13485 and FDA 21 CFR 820
• Experience with technical writing and document management system tools
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.
