Job Description
Job Title: Quality Officer – Quality Management System, 100% in Switzerland
Location: Coppet or Dübendorf (with remote possibility 2 times a week)
The Quality Officer provides active support for quality assurance within laboratories and the quality team through effective quality system management.
Responsibilities:
* Manage the document control system (review, filing, archiving).
* Contribute to the development and improvement of the management system.
* Train staff or coordinate training on quality policies and procedures.
* Analyze data to identify process gaps, training needs, and drive improvement actions.
* Support quality managers with non-conformities, corrective actions, preventive actions, and change management.
* Coordinate the closure of quality management system records (non-conformities, adverse events, changes, etc.).
* Monitor and ensure high-quality laboratory services.
* Assist in preparing for audits and regulatory inspections.
* Prepare responses to regulatory inspections.
Profile:
* Degree in life sciences, medical laboratory science, or quality.
* Fluent in French and German; English is an asset.
* Minimum 2 years' experience in a quality role within the life sciences industry.
* Knowledge of ISO 15189, ISO 17025, and IVDR (or ISO 13485).
* Audit experience.
* Proficient in MS Office.