Location: France Duration: 6 months plus Description: The client, who develops invitro diagnostic products (reagents, software, etc.) for use in oncology/cancer therapeutics, is looking for an experienced Quality Consultant with expertise in IVD products / IVDR regulations. The client had a combined IVDR, ISO 1345 and MDSAP audit with multiple findings. The client developed two different action plans; One workstream is related to IVDR/ISO 13485 and MDSAP re-certification and remediation of audit findings and the other addressing a backlog of CAPAs, NCRs that may require improving their CAPA process. The consultant will help the client to prepare for the re-certification audit in the context of implementation of two big action plans and improvement of the CAPA process. The consultant will need to be an expert in the management of CAPAs, performing root cause analysis, CAPA implementation, CAPA follow-up, and experienced in how to reduce the backlog of NC. Must have IVD product / IVDR regulation experience/expertise and speak/communicate effectively in both French and English.
EU: IVD Expert (235732)