SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
The companyOur client is a professional Medical Devices organization, based in Noord-Brabant Netherlands. This organisation is active within the Dental industry. There are manufacturing and developing high-technologic and innovative products for dental professionals. This organisation is rapidly growing and is aiming to expand their business across borders, therefore they are looking for additional support.
Role descriptionQuality is essential for this organisation. You are responsible for the maintenance and improvement of the Quality Management System, which requires knowledge of the ISO 13485: 2016 standard and relevant legal and regulatory documentation. You are involved with internal and external audits, which you will guide from the beginning to the end. In addition, you are the contact person concerning QMS discrepancies and solutions. You have a major role when it comes down to giving recommendations and advice about QA, and you will create awareness within the organisation across other teams. This role is set for 2 months with possible extension to 6 months.
ResponsibilitiesAs mentioned previously, you are playing a major role in advising the organisation about Quality Assurance and Regulatory Affairs. On a daily basis you are completely involved with the Quality Management System. Further responsibilities include:
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Offering guidance regarding risk assessment and CAPA’s in order to meet the regulatory standards
• Ensuring compliance for product launches and product registrations for existing and new markets
• Establishment and maintenance of relationships with departments and external stakeholders on a global level
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
Requirements• Bachelor in Life Sciences
• Minimal 10 years of experience within the Medical Devices industry
• Minimal 7 years of experience within a QA role
• Excellent knowledge of ISO 13485: 2016 standards
• Broad knowledge of European and international regulation
• Fluency in both Dutch and English
• Eye for detail and excellent analytical skills
• Proven experience in improving and developing Quality Management Systems
• Pro-active attitude
• Excellent problem-solving skills