Role DescriptionIn this particular job as auditor for the Medical Devices, you will visit organisations where you will certify their quality management systems. You will perform the audits according ISO 13485 standards and European regulations. You will be giving advice and coordinate certification procedures for clients. From time to time you will visit clients abroad.
ResponsibilitiesYou will receive the responsibility to ensure compliancy of the QMS from other companies. Furthermore, your tasks involve: • Guiding organisations with the implementation of regulations and adaptations of the QMS • Offering assistance in ensuring that the client is following up on the correct changes within the regulations and standards • Helping out the company with further developments in relation to the assessment of medical devices and/or environmental management systems.
Requirements• Bachelor or Master in Life Sciences • Minimal 5 years of experience in the Medical Devices industry in both manufacturing and distribution environments • Excellent knowledge of GMP, ISO 13485, 21 CFR Part 820 • Great knowledge of relevant regulations from the European and international markets (such as FDA and CE- marking) • Excellent analytical and problem-solving skills • Fluency in English, Dutch and business level French • Strong in communication skills • Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders • Individual operator yet 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.