Lund, Sweden
CoFounder and VP QA&RA at QAdvis
Medical Devices
Education
Lund Institute of Technology, Lund University 1986 — 1991
M Sc EE, Electrical and Biomedical engineering
Experience
QAdvis October 2013 - Present
Synergus AB October 2011 - October 2013
Bactiguard AB January 2010 - October 2011
Synergus AB October 2007 - January 2010
Gambro July 2002 - July 2007
Gambro July 2001 - June 2002
Gambro June 1996 - June 2001
Gambro February 1995 - May 1996
Gambro April 1991 - January 1995
University Hospitals: Sweden, Saudi Arabia, Norway August 1982 - July 1986
Skills
Manufacturing, Biomedical Engineering, Regulatory Affairs, Quality Management, Operations Management, FDA GMP, Regulatory Submissions, Risk Management, Design Control, Lean Manufacturing, ISO 13485, ISO 14971, Validation, Strategy, Product Development, Quality System, Regulatory Requirements, Change Control, Interim Management, GMP, Iso 9000, Quality Auditing, Guitar player, V&V, Production Managment, Quality Control, CAPA, ISO, Process Engineering, Medical Devices, Quality Assurance, ISO 9000