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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.

Responsibilities:

  • 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.

Requirements:

  • 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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