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 Gelderland Netherlands. The company is a global leader in technical services with a medical device branch with much growth potential and ambitious goals for the future.
Role descriptionDue to a fallout of the current manager they are looking for a new Quality Assurance Manager to take over all tasks and responsibilities. You will supervise the team and improve and maintain compliancy for all medical device products regarding regulations and quality. Goals are to expand the team in the future that you will supervise, train and evaluate beside your daily tasks. If tasks will seem too challenging and take too much time you will receive a Quality coordinator to support you in this.
ResponsibilitiesBesides supervising the team you will be end-responsible for the QMS and serve as a contact person in EMEA. As the new QA Manager you will lead audits and conduct analysis to find opportunities to improve the current systems and ensure compliancy of ISO 13485 & ISO 9001 and FDA. It is your responsibility to increase quality awareness and change management accordingly.
Requirements• A degree in a science related field
• Minimum of 5 years QA experience within a highly regulated environment (Medical/Pharma etc)
• Deep knowledge and understanding of ISO 13485
• At least 2 years of experience as QA manager
• Knowledge of FDA, MDD, MDR is preferable
• Fluent in Dutch and English