Hamza Belmihoub

Quality Manager in charge of ISO 13485 implementation and 2017/745 regulatory compliance. ERP Project Manager. Responsibilities: 1. ISO 13485 QMS implementation - Creation of quality documentation for each process (procedures, instructions, forms) - Creation of Excel work tools (monitoring tables, etc.) - Monitoring and control of monitoring indicators and risk assessment for each process - Creation and control of quality control checklists for each product - Control of corrective actions for each process - Monitoring of curative and corrective actions to ensure product conformity - Process audits - Monitoring of new product listings 2. Regulatory compliance 2017/745 - Creation and updating of technical documentation for medical devices (risk analysis, CE declaration...) - Regular exchanges with suppliers (France, Europe, Asia) - Regulatory watch - Drafting of instructions for use by product - Creation of labels (barcode, reference...)

Development of the quality culture within the teams Animation of problem solving workshops (QRQC, Quality Alert) Drafting of quality incident sheets, measurement sheets Drafting of product follow-up documents (Monitoring of Repair Operations, Control Report, etc.) Management of internal and external exemptions Development of training material Customer sourcing

Develop the process approach. Lead and coordinate ISO 9001 working groups. Ensure regular communication around ISO 9001 certification. Deploy the culture of evaluating actions and using quality indicators. Root Cause Analysis Participate in the implementation of the quality documentary system. Participate in internal quality audit work on the group scope. Regulatory Assesment (EHS), Manage the EHS system Deployment of a multi-site EHS system Analysis of work accidents

Support the appropriation and monitor the implementation of the Group Quality Policy. Produce the quality documentation required by the requirements of the standard. Ensure regular communication around ISO 9001 certification. Lead and coordinate working groups with a view to CE certification (Machine Directive). Take a lead role in the deployment of the Machine Directive within the Equipment division. Realization of Machine and Process FMECAs Creation of the technical file for the entire machine park (12)