Lead Quality Engineer QS (5307)
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Lead Quality Engineer QS
Our client is a Medical Device company with a focus on Ophthalmology located in the East of Switzerland. We are looking for a Lead Quality Engineer QS for a permanent position to be based in the St. Gallen area of Switzerland.
- Provide technical support of the development teams with quality-related issues;
- Create test concepts for components/assemblies in cooperation with development, process development and suppliers;
- Independently plan and implement supplier audits, as well as monitor deviations (including effectiveness checks);
- Develop of processes within the QA topics;
- Monitor and process non-conformities to ensure an adequate and timely completion of tasks;
- Identify and track error messages from suppliers in German and English in coordination with procurement;
- Manage suppliers in quality related topics;
- Collect, maintain and systematically analyze/evaluate quality data;
- Implement and ensure continuous improvement of the quality management system to ensure product quality and regulatory requirements;
- Lead internal QA training courses.
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Engineering FH/Uni degree, preferably in the field of medical technology or comparable with a focus on quality management;
- Professional experience in the QM environment in medical technology, pharmaceutical industry or comparable highly regulated field;
- In-depth knowledge of European and US regulations, directives and standards (EN ISO 13485, Regulation (EU) 2017/745 (MDR), FDA 21 CFR 821 etc. or a comparable industry such as pharmaceuticals);
- Very good knowledge of spoken and written German and English.
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