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. In addition, you are responsible for the ISO 13485 standards and required documentation. You will be the key person to contact whenever there are any issues or questions about the Quality system, ISO standards and required documentation. You will closely collaborate with the various departments within the organization to guarantee overall compliancy.
ResponsibilitiesOn a daily basis you are involved with overviewing and maintenance 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 • 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 in engineering • Minimal 2 years of experience with QA on a production site within the Medical devices or Pharmaceutical industry • Proven experience with the maintenance and improvement of QMS • Experience with audits and inspections of notified bodies and other authorities • Excellent knowledge of American and European legislation and regulations • Fluent Dutch language and business proficiency English • 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.