SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Oost-Vlaanderen Belgium.
The CompanyThis company is looking for excellent auditors. They are an international organisation that provides certifications for Life Sciences companies. As quality and regulations become more strict and complex, they are looking for some new employees.
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
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.