Baden-Baden, Baden-Württemberg, Germany
QM and Verification & Validation Projects, Medical Device Labeling & Packaging / Document Translator
Medical Devices
Education
SQS QUALICON AG, Switzerland 2012 — 2012
External & Internal Auditor
Edwards Lifesciences Internal Training Institute 2009 — 2009
Software & Application Validation
Swiss Packaging Institute in Bern, Switzerland 2006 — 2006
graduated, Packaging Generalist
Business Training Centre, Luzern, Switzerland 2005 — 2005
Project Management, graduated
MD Consulting SA, Switzerland 2005 — 2005
Coaching for Executive Management
SMI Zofingen, Switzerland 2002 — 2005
Desktop Publishing QuarkXpress Passport, MAC OS 9 / OS 10
Neosys AG, Switzerland 2002 — 2002
Process Oriented Quality Management ISO 9000
Migros Club School, Luzern, Switzerland / IT 2001 — 2002
MS Office Master, graduated
Università per Stranieri di Perugia 1990 — 1990
ltalian Language, Culture and Society, graduated
Swiss Railways Training Institute 1985 — 1987
Service Management and Traffic Planner, gratuated
Experience
Paterson Associates Ltd. January 2013 - Present
Perlen Packaging January 2013 - July 2013
Perlen Packaging January 2012 - December 2012
Edwards Lifesciences 2002 - 2011
Roche Diagnostics AG, Rotkreuz 2007 - 2008
Werthenstein Chemie AG, Schachen 2001 - 2002
Intigena Vetriebs- und Marketing AG, Zug 1993 - 2000
Skills
New Business Development, Quality Management, Quality Auditing, Lean Manufacturing, Software Documentation, Packaging Engineering, Commercialization, Regulatory Affairs, R&D, Supply Chain Management, Regulatory Requirements, Business Analysis, FDA, ERP, Quality System, Pharmaceutical Industry, Packaging, Design Control, Medical Devices, V&V, Computer System..., Process Improvement, Project Management, Business Process..., Product Development, ISO, Software Quality..., Manufacturing, Sop, Requirements Analysis, Product Launch, Process Simulation, Validation, Continuous Improvement, ISO 13485, Process Engineering, Technical Translation, Quality Assurance, Testing, Translation, Root Cause Analysis, Document Management, Business Planning, GMP, Technical Writing, Design of Experiments, Cross-functional Team..., Supply Chain, CAPA