Nathalie Eisenbraun

Merger of Roche Diabetes and Roche Diagnostics documentation.

✓ Document management without an EDM system: harmonization of processes and quality references.

✓ Technical coordination across departments (Medical, Legal, QHSE, SAP ERP, Sales, Marketing, Logistics, Metrology).

✓ Implementation and facilitation of quality review and documentation progress meetings.

✓ Structuring of the document hierarchy and optimization according to the ISO 9001 standard.

✓ Contribution to the 5S project to support management in improving organization and performance of the document management process through the proposed Flow Diagram method.

✓ Negotiation and retrieval of the key supplier management file for the Supplier Quality Manager.

✓ Follow-up, reminders, and recognition of internal stakeholders, using a step-by-step approach.

✓ Team awareness and training on the use of Google Workspace to facilitate team integration and change management.

• Maintained EN9100, Part 21G, and DOA certifications, with reporting to executive management.

• Created and implemented quality KPIs for managing three regulatory frameworks.

• Advised CEO on management tools and governance rituals.

• Deployed 5S, internal audits, SIM (short interval management), Lean tools. . Conducted Lean training and launched an internal training plan for a critical machine.

• Assessed, qualified, and audited suppliers; direct contact with critical subcontractors.

• Managed documentation through QSAAS.

• Led actions via WRIKE.

• Analyzed key employee motivation and implemented a retention plan.

• Contributed to security management; Improved metrology function and suggested a certified service provider.

• Liaised directly with management, R&D, and production to ensure quality and tech teams alignment.

• Shared expert contacts to support start-up growth.

Daily use of English . Conducted R&R audits for operational control and quality alignment . Cut service budget Updated documentation Worked with the design office to improve product design for ISO 13485 compliance Delivered 40+ ISO 13485/GMP training sessions to 200+ employees .

• Boosted training KPI to 95% through process improvements Created and rolled out structured onboarding for new hire . . .

• Introduced 3D control method to reduce production NC Optimized metrology: - 40% time, reduced costs . Tools: Cornerstone (LMS), Power BI, SharePoint, MS Office.