Design control specialist
Since December 2013
In the current position, project leader and responsible for the management and organization of the design control activities according to ISO 13485. Involved in Risk management process arising from the application of ISO 14971. Involved in certification activities together with Regulatory department in order to prepare technical file documents (STED) for CE conformity and CE mark renewals as set out in annex II.
R&D Sr. design control specialist
Since December 2012
R&D quality assurance specialist
November 2012 --- December 2013
R&D quality assurance specialist Involved in write and organize the technical documentation of the R&D projects, according to the actual directives for medical devices. Skills acquired in the preparation of the dossier that have to be submitted at Notified Body, for obtain the CE mark approval. Ability to write and maintain the Risk analisys tables.
December 2008 --- November 2012
R&D Laboratory specialist Experiences on new products development and feasibility studies: set up of analytical methods (HPLC, GC and UV), thermal characterization of the formulations (DSC and TGA) and dissolution tests on final device. Validation of analytical methods both for quantification and quality control. Preparation of SOP for production and quality control use.
June 2006 --- November 2008
Chemical and drug application_ Vascular Therapy department - Drug eluting stent developement. - HPLC, UV, DSC and TGA analysis for developement and stability data. - Analytical support for quality control
February 2005 --- May 2006
in final project experience from Aston University in 2004
Chimica e Tecnologia Farmaceutiche in Pharmaceutical from Università degli Studi di Pavia in 2004
Training and Certification
Auditor ISO9001, ISO19011 Certification
Internal auditor ISO 22000, BRC; IFS Certification