Quality Assurance coordinator Ophthamology
Location: NetherlandsSIRE 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 COMPANY
Our client is a professional Medical Devices organization, based in Gelderland Netherlands.
This organisation is a manufacturer and wholesaler for contact lenses that are applied via surgery. They established a broad network of suppliers, with whom they collaborate on an international scale. They are focused on highly technological and innovative products. Their business is growing, therefore they are currently expanding their organisation.
ROLE DESCRIPTION
Quality Assurance is of high importance within this organisation. You will become part of an ambitious, yet informal business setting. You will have a dynamic role in which the importance lies on the maintenance and improvement of the QMS, in combination with the responsibility to control and interact on international legislation and regulation standards. Furthermore, you are guiding internal and external audits. You will be the key contact person when it comes down to quality and regulatory issues and questions. This role is set for 5 months with a possibility for extension to 8 months.
RESPONSIBILITIES
Overall, you will be seeking for opportunities to improve the Quality Management System. You will be involved with particular Quality and Regulatory cases, in which you gain the opportunity to exchange your opinions and share your knowledge. Further, responsibilities involve:
• Identifying points of development for the QMS and making adjustments in relevant documentation
• Creating awareness of importance RA and QA within the corporate organisation by using internal resources
• Providing advice and support to management in set up of QA/RA processes
• Management and control of QMS documentation and reviewing these documents
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
• Controlling and assessment of promotion materials with relevant documentation and product specifications
REQUIREMENTS
• Bachelor in Life Sciences
• Minimal 5 years of experience within the Medical Devices industry
• Minimal 3 years of experience within a QA role, containing in particular ISO 13485
• Fluency in both Dutch and English
• Eye for detail and excellent analytical skills
• Pro-active attitude
• Strong communicator and problem-solving 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.
