A market leader in non-invasive technology is seeking a QARA Manager to join their expanding site in Neuchatel. This role offers an opportunity to be part of an international, fast-paced organization that is building a new division and undergoing significant transformation. The position provides excellent future development prospects, an international working environment, and a competitive compensation package.
Responsibilities :
1. Develop and maintain the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, and MDSAP standards.
2. deputize for the QMR and PRRC as required.
3. Conduct internal audits and support external audits.
4. Perform root cause analyses and implement CAPAs.
5. Conduct risk analyses following ISO 14971 standards.
6. Assist in compiling technical documentation for manufactured products.
7. Support the registration and ongoing maintenance of product registrations worldwide.
Requirements :
1. Minimum of 4 years' experience in the medical device industry, with at least 2 years in quality management.
2. Expert knowledge of ISO 13485, MDSAP, ISO 14971, and MDD / MDR (2017 / 745).
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