Mauro A. Rodrigues

- Coaching & supporting 3 teams in agile frameworks (Scrum, LeSS, Kanban) to promote self-organization and responsibility; - Successful scaling with LeSS, making it future-proof and expandable; - Introduction & implementation of a Kanban system from scratch, including WIP limits, replenishments and more; - Ensuring & coaching compliance with the Scrum, LeSS and Kanban processes; - Promotion of an agile department culture through targeted coaching and support of the teams in process optimization.

- Coordination of projects & support of the departments in the fulfillment of all regulatory requirements; - Monitoring and management of certification processes acc. to MDR and ISO 27001, as well as regular implementation & support of int./ext. audits; - Cross-department creation & implementation of processes in the QMS, as well as data protection; - Ensuring the conformity of docs and processes with all relevant regulations, guidelines & standards for the EU area (ISO 13485/ISO 14971/IEC 62304/IEC 62366).

- Support in planning, conducting and oversight of key regulatory tasks & documentation (e. g. clinical evaluation, safety reports, post-market surveillance) - Support in planning, conducting & of key data security activities - Support in Quality Management initiatives - Communicating with regulatory authorities, notified bodies & partners - Building up and maintaining good knowledge about medical device norms and regulations related to GAIA's product portfolio & data security

- Quality management and safety: status quo, structuring, planning and implementation; - Adaptation and continuous updating of the QM/QS areas to the valid legal system; - Planning, implementation and training of HACCP and security concepts; - Coordination and monitoring of the ext. pest monitoring; - Receipt of goods, quality control and documentation; - Preparation of int. and ext. audits.

Im Bereich Incoming Inspection - Supplier Quality tätig: - Unterstützung bei der Messdatenerfassung anhand einer Bluetooth-Verbindung - Anbindung von Messmittel und -Instrumente in der SAP-Datenbank - Non-Conformity Management anhand des SAP-Systems - Unterstützung bei der Anlage einer neuen Ordnerstruktur in der IT-Landschaft - Vollständige Prüfung und Freigabe der Ware - DIN EN ISO 9001, DIN EN ISO 13485

Schwerpunkt Produktionstechnik & Minor in Betriebswirtschaftslehre. Kernfächer: Mathematik für Ingenieure I & II; Werkstoffkunde I & II; Technische Mechanik I & II; Fertigungstechnik I, II & III; Qualitätsmanagement; Lean Management; Elektrotechnik I, II & III; CAD und Produktionssystematik.

Schwerpunkt: Qualitätskontrolle. Kernfächer: Mathematical Analyses; Chemical Analyses of Foods; Organic Chemistry and Biochemistry; Food Processing and Preservation; Food Technology I & II; Rheology and Food Structure; Industrial and Food Microbiology; Economics; Statistics; Phisics I & II.