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Quality Systems 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 Biotechnology, Medical Devices and Pharmaceutical organization, based in Zürich Switzerland.
My client is a European operating medical device company. It has been serving the diagnostics industry from her headquarters in Zurich, Switzerland for over 30 years. The company is very people minded, and are currently investing a lot in quality, R&D and production technology.
Due to a maternity leave there is a interim Quality Assurance position open, but this role will not be babysitting the Quality department. Because of the growth over the past years, the company has to revise its QMS en Quality Program. During this six months your activities will be making a extension to the QMS and make it complaint to the ISO13485/9001. The Quality Assurance interim function contains to obtain the field complaints. With this field complaints you will define trends and where necessary will act with corrective or preventive actions.
- Responsible for proactively making the extension of the QMS, compliant to ISO13485/9001.
- Write the new protocols and rewrite the existing protocols.
- Handling of CAPA's.
- Coordinate SOP's
- Manage and be supportive to the company internal and Notified Body external audits.
- Prepare external audits
- Ensure that the company's QMS is compliant with their up to date Quality Assurance policy.
- Degree in Life sciences or Engineering
- Profound knowledge building or revising QMS
- 5-10 years of work experience: Has been Quality Assurance Manager and/or Engineer in Medical Devices
- Profound knowledge of ISO 13485 and ISO 9001.
- Profound knowledge of MDD 93/42/EEC and FDA 21CFR820
- Fluent in English, fluent in German a big plus
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.