Quality Assurance Specialist
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.
The CompanyThis organisation is developing devices that are constructed for heart diseases. Their aim is to help clients by the creation of innovative and highly technological devices. They are operating on an international level varying from the United States, Latin America and Asia.
Role DescriptionQuality is key to this organisation. On a daily basis you are supporting the operations department from a QA perspective, in order to ensure that their devices are compliant with both internal and external regulations and quality standards. You will focus on the Quality Management System and required documentation. You will be the contact person when it comes down to issues regarding Quality Assurance and particular standards. This project is for a period of 4 months with a possible extension to 6 months.
ResponsibilitiesAs Quality specialist your main responsibility is to improve and maintain the Quality Management System and involved documentation. Furthermore, you are involved with:
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Providing advice and support to management in set up of QA/RA processes
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
• Creating awareness of importance RA and QA within the corporate organisation by using internal resources
• Controlling and assessment of promotion materials with relevant documentation and product specifications
Requirements• Bachelor in Life Sciences
• Minimal 3 years of experience with QA on a production site within the Medical devices industry
• Minimal 2 years of experience in an strictly regulated environment
• Proven experience with the maintenance and improvement of QMS
• Excellent knowledge of American and European legislation and regulations
• Fluency in English, and good understanding of the Dutch language
• Critical scope and excellent analytical skills
• Team player, yet individual operator
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.