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 Brabant Flamand Belgium. The are manufacturer of medical devices that are being used in Critical Care, Urology and surgery
Role descriptionManage the onsite EDC Quality Management System and business focused priorities within the QA/RA organization in compliance with the regulatory requirements.
Responsibilities- Quality System compliance to ISO9001, ISO13485, Medical Devices Directive and 21CFR820.
- Manage Non Conformance, Internal Audits and Supplier Assurance processes
- Generate QA reports as
- Ensure all documentation and coordination of compliance is maintained.
Requirements- 5 years of Quality Assurance related experience
- 3 years of QMS experience in ISO 9001 or ISO 13485
- internal Auditor
- SAP experience