Gabriele Catignoli
Angestellt, Medical Auditor, TÜV SÜD Product Service GmbH
Munich, Deutschland
Werdegang
Berufserfahrung von Gabriele Catignoli
- Review of technical documentation and STED documents - Performing gap assessments between Gambro and Baxter technical documentations, with the goal of compliance to Baxter - Providing inputs for required changes to the Senior Management - Development of the CE database for all Gambro medical devices, according to Baxter’s requirements
1 Jahr und 10 Monate, Juli 2013 - Apr. 2015
Quality Assurance Consultant Engineer
METECO s.r.l.
Performing internal audits in biomedical companies (ISO 9001, ISO 13485, MDD 93/42/EEC and GMP) - Orthopaedics prosthesis, electromedical devices and active pharmaceutical ingredients Suplier Quality Auditor Supporting CAPA management SOP development Validation of sampling plans Development of risk analysis (FMEA, ISO 14971)
Ausbildung von Gabriele Catignoli
2 Jahre und 3 Monate, Feb. 2011 - Apr. 2013
Politecnico Milano
Engineering for cell, tissues, biomaterials and biotechnologies
3 Jahre und 6 Monate, Sep. 2007 - Feb. 2011
Politecnico Milano
Fundamentals of electronic, mechanic and biology. Thesis: Production of nano and micro structured substrates with electrospinning. Mark 91/110
Sprachen
Englisch
Fließend
Italienisch
Muttersprache
Deutsch
Grundlagen