Post Market 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 and Pharmaceutical organization, based in Rhône France.
Our client is a Medical Device company in the Rhone-Alpes part of France.
Reporting to the the Post Market Quality Manager, you main tasks:
- Save, collect information and document customer complaints and medical device records in accordance with the Good Practice Group Guidelines and regulations (Europe, USA, Canada, Australia, etc.)
- Carry out investigations (clinical, manufacturing, sales, etc.) to perform the analysis of the causes of complaints;
- Analyze data and customer complaints trends and propose corrective actions (CAPA);
- Under the supervision of Customer Complaints Custodian;
- Respond to requests ANSM and competent authorities;
- Manage materiovigilance: determine Reportability incidents, submit the initial and final reports of medical device to the competent authorities,
- Manage CAST ( "Field Safety Corrective Action") and risk assessment records "Health Hazard Evaluations": submission of FSCA reports to the Competent Authorities, communication with clients, organizing product recalls, reconciliation.
- Participate with the team of the Service Quality System for the realization of internal audits.
Profile scientific BAC + 5 (Engineer, Master 2, Pharmacist ...) dominant quality, you have an experience of at least one year in a similar position in the medical device industry or the pharmaceutical industry. You are fluent in business English and have practiced regularly and in an international environment.
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.