QARA Compliance 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 Switzerland.
The company is certified ISO 13485 and adheres to the EU Medical Devices Directive (MDD) and FDA 21 CFR 820
In this role, you will be supporting the quality department to make sure all quality and regulatory related issues are compliant with the working standards like ISO 13485, ISO 9001, MDD 93/42/EEC and ISO 14971.
- Making sure all processes are compliant with current standards
- Updating, optimizing and maintaining the Quality Management System (QMS)
- Coaching in process improvement
- Working to make processes are correctly documented
- Taking part and leading CAPAs
- Project management for quality projects
- BSc / MSc in Engineering or business, or same kind of experience from previous (professional) experience
- Knowledge of Change Management Systems
- Knowledge of Procedure Writing
- Experience in training personnel in quality standards and compliance related issues
- Knowledge with MS Word (Visio, Power Point, Excel), general databases, SAP
- Fluent in German
- Fluent 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.