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 Dutch manufacturer is an innovative and yet small organisation but is growing rapidly with much potential to grow beyond European borders. Due to this growth the company is looking for a competent Quality specialist that can strengthen the team.
Role descriptionThe position will be partime Quality role where you will take on all Quality related issues within the company and where needed some Regulated affairs. Your main task is to support the current manager and ensure all compliancy concerning the ISO 9001 & 13485. You will with the Quality Manager and regulated affairs team initiate and facilitate companywide strategies to drive sustainable and continuous improvements.
ResponsibilitiesAs the new Quality assurance officer you will make sure that the strategies and the targets made will be hit. Maintaining and improve Quality Management Systems and improve overall knowledge and compliancy according to this System. Other responsibilities are that you will do complaint handling issues and report this back to concerning managers and teams, as the Quality officer you will support and/or work together with Regulated affairs. You will be the point of contact between the multiple teams and report directly to the Quality Manager.
Requirements- 2 - 3 years experience in Quality assurance within Medical Devices
- Thorough knowledge and understanding of ISO 13485, ISO 9001, MDD (MDR is a pre)
- Knowledge of Regulated Affairs concerning Medical Devices is a big plus
- Being able to work independent
- Fluent in English and Dutch