Role DescriptionAs an experienced Quality Engineer, you are involved with the quality system and related activities. On a daily basis you will assess and review the Quality Management System to see if there is need for any changes and/or improvements. You will be a key contact person when it comes down to questions or issues related to Quality for both internal and external stakeholders. Furthermore, you are also responsible for creating awareness and taking initiatives regarding quality within the organisation. This involves collaboration with stakeholders from different departments such as R&D and Sales.
ResponsibilitiesYour priority will be the maintenance and improvement of the QMS. Further responsibilities involve: • Maintenance of the internal and external regulations including ISO qualifications. • To overview processes and applications conducted by your team which includes supplier containment, CAPA’s , Document control, and risk management • Taking the lead in the execution of internal and external audits • Ensuring compliancy for both Quality and Regulatory principles according to the FDA, IMB and notified bodies • Constantly analyzing data and processes to trace risks and identify improvements for the Quality Management Systems. • Maintenance of relationships with both internal and external stakeholders
Requirements• Bachelor in engineering • Minimal 5 years of experience in the Quality Field • Minimal 2 years of experience in the Medical Device Industry • Excellent knowledge of ISO 13485 and 21 CFR Part 820 • Excellent organizational and problem-solving skills • Experience with FMEA, CAPA’s, and root cause analysis • Fluency in English and Dutch • Strong in communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.