For our client, an innovative company that develops, manufactures, and markets medical devices for therapeutic applications worldwide, we are looking for a
Quality Manager (80% - 100%)
Location: Neuchâtel, NE
Start date: Beginning of 2026
Your responsibilities.
- Drive the continuous development and implementation of the QMS in compliance with ISO 13485, MDR, and MDSAP.
- Act as the official Deputy to the Quality Management Representative & PRRC.
- Lead and manage key QMS processes, including Management Reviews, CAPA, Risk Management, and Change Management.
- Take main responsibility for establishing and updating all compliant technical documentation.
- Manage the complete market access registration process for worldwide distribution.
- Oversee and conduct supplier quality management activities.
- Conduct internal audits as per the audit program and support the company during external audits and inspections (Notified Bodies, Competent Authorities).
- Provide dedicated Quality Management support to various projects.
- Monitor regulatory and standard changes, informing management of their impact.
- Maintain the Document Management System and supervise the quality of product realization records.
Your profile
- A minimum of 2 years of experience in a similar Quality Management role within the medical device industry (industrial production).
- Proven experience with international regulatory affairs and risk management.
- Strong, practical knowledge of the core medical device standards and regulations: ISO 13485, MDR, and MDSAP.
- Fluency in both English (written and spoken) is mandatory.
- Proficiency in French and/or German is a strong asset.