Local Quality Assurance Manager
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 Zuid-Holland Netherlands.
This international organisation is responsible for the development and manufacturing of pharmaceutical products, medical devices and consumer products. Their major focus is on diagnostic devices and pharmaceutical packaging. They work to innovation and aim to offer optimal service to their customers.
ROLE DESCRIPTION
In your role as QA manager you will be directing the site. It is your responsibility to assure quality and compliancy. You and your team will develop various strategies to improve and maintain the quality system. You will establish relationships on the manufacturing site and give advice on quality topics. Reports and analyses will be guided by you and you will makes sure the involved stakeholders will be informed. This project is set for 7 months with a possibility for extension.
RESPONSIBILITIES
You will take the lead on the manufacturing site to assure quality. You will make arrangements and control the QMS. Furthermore, your responsibilities include:
• Control and overview Quality Management System documentation and required procedures in line with organizational standards
• Lead and guide internal and external audits
• Key contact when it concerns Quality standards involving ISO 13485, ISO 9001, 21 CFR 820
• Maintenance and establishment of relationships with the production site
• Development of trainings and providing knowledge about Quality, and market developments
REQUIREMENTS
• Bachelor in engineering
• Minimal 7 years of experience in a Medical Device organisation in a QA role
• Minimal 4 years of experience in a Leadership role
• Excellent knowledge and understanding of QMS for medical device organisations involving the ISO 13485 and the 21 CFR 820
• Broad knowledge of European and international documentation and regulatory standards
• Knowledge of Lean six-sigma
• Strong communicator and organizational skills
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.
