Role DescriptionIn your role as Quality Engineer, you will be operating at the manufacturing site. On a daily basis you will have to establish and maintain relationships with various stakeholders within the organisation. You will overview all activities attached to Quality Assurance of the site. Your major task is to advice the engineers and support the team in relation the QMS. Furthermore, you will be assisting that department in collecting required documentation and regulations. You will directly report to the Quality manager.
ResponsibilitiesYour main task is to be on the site as QA expert that supports and advises various stakeholders which are directly involved in manufacturing. Furthermore, your role includes: • Maintain and establish relationships with internal and external stakeholders in the USA and Japan • Improve and maintain the QMS according to ISO 13485 and ISO 9001 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 4 years of experience within the Medical Devices • Excellent knowledge of quality standards such as ISO 13485, 21CFR820, GMP • Excellent knowledge of EU and USA regulation for Medical Devices • Experience with root cause analyses, CAPA’s, and Risk management • A team player, yet strong individual • Fluency in English and Dutch, preferably Business level French • Strong communicator and 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.