Post Market Quality Manager
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 and Pharmaceutical organization, based in Rhône France.
Our client is a Medical Device company in the Rhone-Alpes area.
Reporting to "Regulatory Compliance Leader EMEA," you will have for main tasks:
- Ensure regulatory compliance of customer complaint, medical device, in connection with the claimed repositories (including Directives 93/42 / EEC and the Code of Public Health ...) and the Corporate requirements
- Ensure and accept the replacement of the medical device corresponding to the ANSM,
- Manage "Health Hazard Evaluations" (HHE) for products manufactured by our client "Field Safety Corrective Actions" (CAST)
- Analyze data and customer complaints trends and propose / monitor improvement actions and / or indicators including the review process and quality management review.
- KPI Manager
- Respect deadlines
- Manage, train and develop the Customer Service Complaints
Profile scientific BAC + 5 (Engineer, Master 2, biology, mechanics and materials, general Pharmacist), you have an experience of at least 3 years in a similar position (in the medical device industry or the pharmaceuticals) with responsibility for Manufacturer responsible and coaching experience. You are fluent in business English and have practiced regularly and in an international environment.
Advantageous: You know the requirements of ISO 13485: 2003, Directive 93/42 / EEC with regard to their involvement in the management of customer complaints. Ideally, you have knowledge of the following standards: FDA 21 CFR 820 (QSR), Canada (RIM), Australia (TGA).
Knowledge of SAP would be a plus, as well as tools for risk analysis or FMEA products (ISO 14971).
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.