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Quality Engineer Design & Production
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 Zürich Switzerland.
The company produces Class III products and adheres to all ruling EU and US quality standards like ISO 13485, FDA 21CFR 820 and the MDD 93/43/eec.
In this role, you will be one of the all-round quality engineers in the quality department. This means you will be working together with the both the R&D, Production, Operations, Customer Service and Sales departments to make sure the quality of the products is of the highest possible standards.
- Part of the R&D team as quality responsible, overseeing compliancy with Design Control standards (FDA 21 CFR 820.30)
- Making sure quality standards apply when transferring products from R&D to production
- Supporting the operations and production department with optimization of new manufacturing processes
- Creation of Risk Management documents for both internal and external made products
- Review and approval of qualification / validation (IQ, OQ, PQ)
- Assessment and evaluation of non-compliant products in current production (NCRs)
- Taking part in CAPA process, from opening CAPA to implantation
- Analyzing the quality system for continuous improvement
- BSc / MSc in Technics, or same type of study in Quality
- Knowledge of FDA 21 CFR 820, ISO 13485 and MDD 93/43/eec
- Previous knowledge and experience with Design Control (DHF, DMR, FDA QSR 820.30 or alike)
- Previous experience in the quality department
- Fluency in German
- Fluency in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.