Sr. Quality Engineer
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!
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
Medical Devices company looking for a Sr. QA Engineer for a project of 6-12 months on site. Available in less than 2 weeks time would be great.
- 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.
- 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
- Organized and structured way of working
- Customer focused and accurate
- Good judgement; showing business acumen, quality, perspective and problem solving.
- Thinking in solutions, socially skilled.
- At least 5 years professional experience
- Experience in Leading a Team and Auditing
- Experience in Regulatory and Customer focused organization
- Experience in a Pharmaceutical and/or Medical Devices company.