Phi Long Tran

• Coordinate QA in serial production & NPI • Manage supplier complaints & root cause analysis (8D, CAPA) • Lead weekly quality meetings (FPY, corrective actions) • Collaborate with Production, R&D, Purchasing & Suppliers • Enhance SAP traceability & support audits/improvement projects

• Supported planning and execution of process validations (IQ, OQ, PQ) for cleaning and laser marking processes • Contributed to Computer System Validation (CSV) • Created and maintained pFMEAs to ensure product safety and compliance • Authored SOPs, inspection protocols, work instructions and maintenance plans • Participated in the establishment and maintenance of a quality management system compliant with ISO 13485 • Took part in customer audits and supported CAPA documentation and follow-up activities

• Supported P-FMEA sessions using QSys • Developed bilingual work instructions and inspection guidelines • Assisted in tooling documentation and complaint process translations

Warehouse logistics and service personnel

• Supported P-FMEA sessions using QSys • Developed bilingual work instructions and inspection guidelines • Assisted in tooling documentation and complaint process translations

• Digital revision of brochure material • Creation of rendered images from 3D construction data in SolidWorks

• Gained hands-on exposure to medical device manufacturing and engineering processes • Assisted with Change Request processes and documentation

Schwerpunkt Konstruktion, Fertigung, Betrieb Zusatzleistungen: FEM-Praktikum mit ANSYS, Höhere FEM-Simulation mit ANSYS, Praktikum Schweißtechnik und trennende Fertigungsverfahren, Materialfluss und Logistik, Projektmanagement und Industrielle Planungsverfahren, Sozialkompetenz I, Einführung in das Recht I