Munich Area, Germany
Head of Quality Management / Quality Management Representative
Medical Devices
Education
Fachhochschule Lübeck und der Universität zu Lübeck 2014 — 2015
Manager Regulatory Affairs Medical Devices, Regulatory Affairs
Fachhochschule Albstadt-Sigmaringen - Hochschule für Technik und Wirtschaft 2001 — 2005
Dipl. Ing., Pharmaceutical Technology and Quality Management
Experience
Pulsion Medical Systems SE October 2012 - Present
Acino AG February 2010 - September 2012
Syntacoll GmbH July 2009 - October 2009
Daiichi Sankyo Europe GmbH September 2006 - June 2009
Haupt Pharma Wolfratshausen GmbH June 2005 - August 2006
Tyco Healthcare Manufacturing GmbH August 2001 - February 2005
Pharmacy September 1995 - August 1999
Skills
OOS, ISO 13485, 21CFR 820, Project Management, GMP, QMB TÜV zertifiziert, Auditing, Quality Auditing, CAPA, Qualitätsmanagementsyste..., Supplier Quality..., Compliance, Quality Control, ISO 9001, Medizinprodukte, Regulatory Affairs, Qualitätsaudit, Pharmaceuticals, Pharmaceutical..., cGMP, ISO 14971, QMF TÜV zertifiziert, MDD, Quality Management, Change Control, Qualitätsmanagement, Medical Devices, Validation, 93/42/EWG, Qualitätskontrolle, Deviation Management, QMA TÜV zertifiziert, SOP, Lebensmittelüberwachung, 93/42/EEC, Quality Assurance, Qualitätssicherung, Pharmaindustrie