Quality Engineer
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 Noord-Holland Netherlands.
Manufacturing MD company.
ROLE DESCRIPTION
Support the growth and development of the Quality Assurance organization and assure a permanent state of quality compliance
Quality and Compliance activities on an operational and tactical level. For both production and pre-production. Also required to consult on a strategical level.
Back-up Quality Manager.
RESPONSIBILITIES
- Generate, review and authorize Quality related documents;
- Maintain the CAPA (Corrective and preventive actions) system;
- Maintain the complaint handling system
- Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action;
- Analyze data concerning production, processes and the quality management system and propose improvements
- Release products, processes and equipment based on statistical data;
- Execute internal and external audits including reports;
REQUIREMENTS
- Coaching and Management capabilities
- Good Manufacturing Practice
- Quality Management Systems (ISO13485. FDA 21CFR820, MDD 93/42EEC or similar)
- EO sterilization
- Cleanrooms/ microbiology
- Process validation
- Knowledge of Lean Six Sigma tools and project management
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
