Quality Management Systems 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.
Our client is a professional Healthcare and Medical Devices and operates at an international level. They are one of the leaders in technological developments and innovation. They are active within a broad range of technology-driven industries, varying from household products to healthcare devices.
ROLE DESCRIPTION
In your role as Quality Management System Manager, you are responsible for a particular system of the organisation. On a daily basis you are involved with regulated standards, compliancy and you are overviewing developments and required changes within the QMS. You are in charge of tracking and being fully aware of all changes within the regulatory domain for Europe and the US. This project is set for 1 year with a possibility for extension.
RESPONSIBILITIES
Your daily responsibility contains the overview and maintenance of the QMS for this particular site including the relevant documentation. Furthermore, you are responsible for:
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Support during internal and external audits
• Controlling and assessment of promotion materials with relevant documentation and product specifications
• Management and control of QMS documentation and reviewing these documents
• You will be on track with the latest developments and changes of QA within the Medical Devices sector
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
• Review and assessment of procedures involving risk and validation management at the manufacturing site
• Development of strategic plans and implementation tools for the improvement of the Quality Management System
REQUIREMENTS
• Bachelor of Science
• Minimal 3 years of experience with QA on a production site within the Medical devices industry
• Knowledge of Lean-six sigma procedures
• Evidence of maintenance and improvement of QMS
• Basic understanding of the differences in medical device legislation from other continents
• Team player and pro-active attitude
• Fluency in English, and good understanding of the Dutch language
• Excellent analytical skills and capabilities
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.
