Manager Medical Device Audits
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 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 your position as technical manager, you will gain the responsibility to ensure the quality of the company’s auditors. On a daily basis, you will provide support to the auditors in the field. Furthermore, you will keep track of the developments within the Medical device market concerning quality and regulatory activities. You are the key person when it comes to guidance, coordination and insurance of technical qualifications for the auditors.
ResponsibilitiesOn a daily basis, you will support the auditors with their projects. Furthermore, your responsibilities contain:
• Assess and improve technical qualifications of the staff members
• Achievement of company targets
• Scheduling and execute QMS audits for the medical devices sector according the company’s procedures
• Assessment of audit results and certification matters
• Create cohesion and collaboration within the organization
• Point of contact whenever there are issues with clients, notified bodies and other authorities
Requirements• Bachelor or Master in Life Sciences
• Minimal 5 years of experience in the Medical Devices industry in both manufacturing and distribution environments
• Extensive experience with medical devices varying from class I to III
• Excellent knowledge of ISO 13485
• Great knowledge of relevant regulations from the European and international markets (such as FDA and CE- marking)
• Preferably experience as (Lead) auditor
• Excellent analytical and problem-solving skills
• Fluency in English, Dutch and business level French
• Strong in communication skills
• Excellent organizational and managerial skills
• Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders
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.