Role DescriptionQuality is set at a high standard. You will focus on the QA processes and procedures for the EMEA region. 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. In addition, you will make sure all required documentation is collected and related tasks are executed. You will become part of a dedicated and passionate QA team where you receive plenty of opportunities for personal and professional development.
ResponsibilitiesAs Quality Process Specialist your main responsibility is to be involved with operational and back office QA activities. Furthermore, you are involved with: • Identifying points of development for the QMS and making adjustments in relevant documentation • Collecting and creating reports of outcomes from investigations/audits especially for CAPA’s • Supporting audits for the EMEA region • Management and control of QMS documentation and reviewing these documents • Providing input and support to management in set up of QA/RA processes, activities and procedures • Interaction and communication with both internal and external stakeholders
Requirements• Bachelor in Life Sciences • Minimal2 years of experience in an strictly regulated environment • Knowledge of ISO 13485 or ISO 9001 • Proven experience with the maintenance and improvement of QMS • Fluency in English and Dutch business level understanding • Excellent analytical skills and organizational capabilities • Evidence of experience in working on a project basis • Excellent creative thinking and a problem solving mindset • Team player
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.