Role DescriptionQuality is set at a high standard. You will focus on the Quality Management System and required documentation for the European and Japanese, and US standards. On a daily basis you are supporting the QA team in the development and improvement of the Quality System. You will be creating procedures and strategies that ensure that the devices are compliant with both internal and external regulations and quality standards. 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 increase and maintain the Quality Management System and involved documentation. Furthermore, you are involved with: • Collecting and creating reports of outcomes from audits especially for CAPA’s • 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 • Management and control of QMS documentation and reviewing these documents • Execution and guidance during internal and external audits, and being the contact person for any occurring issues • Assisting in the development of trainings and tools regarding quality issues
Requirements• Bachelor in Life Sciences • Minimal 5 years of experience with QA on a production site within the Medical devices industry • Minimal 3 years of experience in an strictly regulated environment • Excellent knowledge of the ISO 13485, US and Asian quality standards and broad knowledge of these regulations • Experience with the maintenance and improvement of QMS • Experience with clean rooms • Team player with extraordinary communication skills • Fluency in English, and good understanding of the Dutch language • Experience as auditor for both internal and external stakeholders • Critical scope and excellent analytical 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.