Complaint Engineer / Quality Assurance
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 Biotechnology and Medical Devices organization, based in Antwerpen Belgium.
is a developer and manufacturer of high innovative Medical Devices/IVD. They are a rapidly growing and becoming increasingly influential in the IVD industry.
The Quality Engineer Complaints will coordinate the follow-up of complaints, in close collaboration with all departments involved (primarily coordinating with the Customer Service, Sales, System Engineering, Supply chain and Manufacturing Departments). The Quality Engineer will report to the QMS Manager.
- Proactively manage complaints
- Review all registered complaints for completeness
- Drive investigations in collaboration with other departments, related to complaints, to obtain thorough root cause analyses and adequate definition of an action plan to resolve complaints
- Coordinate CAPA actions related to complaints, and follow-up of their timely implementation and effectiveness;
- Develop new and improve existing processes and procedures related to complaints;
- Organize and provide training of personnel in relation to management of complaints;
- Identify complaint trends and call for action from the organization when action is needed to improve trends that require improvement;
- Present KPI data on monthly management meetings;
- Participate in audits performed by external parties.
- Bachelor or Master degree in engineering or life sciences (biomedical, chemical, pharma
- 5 years of relevant experience in an Medical Devices/IVD
- Excellent understanding of different national and international quality standards
- Profound experience in participating in deviation investigations, determining root cause, and developing corrective action plans;
- You work very accurately and have an eye for detail;
- Good analytical and conceptual thinking skills with the ability to solve key problems;
- You are an excellent communicator, verbally and in writing, with good decision making skills;
- Able to comprehend processes in short time frames;
- Advanced knowledge, orally and in writing, of Dutch and English;
- Experienced with MS Office (i.e. Word, Excel & PowerPoint).