Experience and background

RESPONSIBILITIES / SCOPE OF POSITIONS

My last employed position in 2014 was ”Senior Quality Auditor” in GE Healthcare (GEHC): As part of an international team I led and performed quality audits of GEHC sites worldwide.  In this function it was important to have strong knowledge base and excellent communications skills, especially as the work was in different cultures world wide. Audits focused on compliance til requirements in ISO 9001, ISO 13485, FDA’s regulations and the CE directive for medical equipment.

Previously I led a team responsible for Quality Systems and Compliance for 24 sites in GEHC. These sites were located in USA, Europe including Israel, and Asia. I had direct leadership responsibility for 5- 8 people and coaching responsibility for the quality teams at the sites.

Quality Systems for medical devices are  dominated by standards and regulations for various countries and marked, and this influences work contents, documentation and philosophy. FDA’s regulations are strict and dominate many Quality System implementations, but usually ISO 13485 and MDD requirements are included in Quality System implementations, in order to obtain CE mark on medical devices.

As manager and quality auditor I have also developed and held training and I am comfortable communicating knowledge in  small and larger  groups of people.

OTHER RELEVANT EXPERIENCE

In the development and revision of quality systems, I have also worked with Environment , Health, and Safety (EHS) and related control systems. In GE Healthcare, this is a large area based on American principles and regulations.

I was also three years project of a joint project with the Norwegian National Hospital (Rikshospitalet) where the aim was to adapt / develop ultrasound equipment for use during open heart surgery, and I was allowed to be present during many operations in several hospitals in the occasion, as well as work closely with surgoans and cardiologists and other specialists.

WORK HISTORY

2009 – 2014 Senior Quality Auditor, GE Healthcare

2006 – 2009 Clinical Systems Site Compliance Director, GE Healthcare

2003 – 2006 Compliance Manger, Ultrasound / Clinical Systems, GE Healthcare

2002 – 2003 Six Sigma Black Belt, Quality management

2000 – 2002 Global Ultrasound Quality Lead, GE Healthcare

1998 – 2000 Quality Assurance Manager, GE Vingmed Ultrasound

1996 – 1998 Project leader, Vingmed Sound

1992 – 1996 Quality Assurance and EHS specialist, Vingmed Sound

1990 – 1992 Probe Director, Vingmed Sound

1988 – 1990 Director of development, Vingmed Sound

1987 – 1988 Department manager, Lehmkuhl Elektronikk

1980 – 1987 Lead Engineer, Manager Engineering, Marine Manager. GECO

1979 – 1989 Programmer, Computas

1973 – 1979 Research Engineer, Det norske Veritas

EDUCATION

1968 – 1972 M SC Automation, Electronics, NTH, Trondheim Norway

1979 – 1981 Marketing and finance, Drammen Nprway

OTHER QUALIFICATIONS

Six Sigma Black Belt

Internationally Certified Quality auditor (QMCE) NFKR

HONORARY POSITIONS

2 year board member Norwegian Association for Quality and Risk Management, from start to 2005.