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 ...
Dettagli di lavoro
- Riferimento24296
N
Nicolas Barthes
i prossimi passi
randstad operational
We find, nurture, and connect uniquely skilled talent with employers when they need it, building successful teams that scale as their business grows while positioning individuals for rewarding careers and businesses for operational success.
Dettagli di lavoro
Start date: Beginning of 2026
Mostra di piùYour 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.
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.
