Role DescriptionYou will become part of an informal and dynamic business setting in which quality is set at a high standard. You will receive various responsibilities that are directed to maintain and improve the Quality Management System according the ISO 13485 standard and related activities. You will be involved with the preparation and execution of internal and external audits, the creation of awareness among other colleagues and customers, and interaction with different departments from a quality perspective. Finally, you will gain insights into improvements and developments for the QA department.
ResponsibilitiesOn a daily basis you are involved with maintenance and improvement of the Quality Management System. In addition, on a daily basis you are involved with: • Development of strategic plans and implementation tools for the improvement of the Quality Management System • Gain insight into possible points of improvements for the QMS according to ISO 13485 standards • Providing support to management in set up of QA/RA processes • Collecting and creating reports of outcomes from audits especially for CAPA’s and performing risk management • 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, involving regulations & legislation such as the MDR and FDA
Requirements• Bachelor or Master, preferably in the Life Sciences • Minimal 2-3 years of experience in a QA position • Proven experience with the maintenance and improvement of a QMS • Experience with audits and inspections of notified bodies and other authorities • Excellent knowledge of American and European legislation and regulations • Fluent in English and preferably Dutch • Critical scope and excellent analytical skills • Result- oriented and a thorough quality mind-set • 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.