1987

Secondary school degree

1989 to 1990

Trainee at the quality assurance laboratory of the Bayer AG, Krefeld

1990 to 1995

Degree as a Chemical Engineer at the University of Applied Sciences in Krefeld with topic on Biotechnology and Biochemistry

1995 to 2001

Chemical Engineer at the Landesumweltamt Nordrhein-Westfalen (Authority for enviromental tasks of the state of North-Rhine Westphalia)

1995 to 1999

Investigation of industrial waste waters  caused by genotoxic potential in the genetic laboratory of the Landesumweltamt Nordrhein-Westfalen

1999 to 2001

Chemical Engineer at the Departement of Approval and Application for Genetic Laboratories

2001 to 2012

Quality management at Sarstedt AG, Germany: QM according to ISO 13485 and 9001, processing of conformity assessment procedures including the preparation of technical files for medical devices, application for medical devices in Canada, update of the qm system of the Australian facility on site, TGA contacts, implementation of a qms at a laboratory device manufacturer, development and application of a procedure for validation of production processes including software, process trouble shooting and optimization of production processes at several sites,  conduction of several supplier-, product- and system audits

2012 to 2018

Auditor and assessor for medical devices at the Notified Body ecm -Zertifizierungsstelle für Medizinprodukte in Europa mbH, Aachen, Germany

- Execution of audits according to annex V and II.3 Medical Device Directive 93/42/EEC,

   including assessment of the quality management documentations

- Almost 300 audits at more than 100 manufacturers in 12 countries, thereof more than 280    audits as lead auditor

- Audits according to  ISO 13485, ISO 9001, ISO 15378

- Production site audits at subcontractors

- Assessment of contractual regulations between manufacturers and subcontractors or OEM    (OBL) suppliers

- Assessment of technical files for medical devices of all relevant classes

- Processing of conformity assessment procedures for certification, extension and changes

- Assessment of validation reports (e.g. sterilisation, packaging, cleaning)

February 2018

Foundation of a consultancy agency for medical devices and quality management systems