Location:
6634 Chadwick Dr, Savage, MN 55378
Work:
Featherstone Compliance Group
Retired
Hospira
Jan 1, 2014 - Jan 2017
Director Regulatory Affairs
Ge Healthcare
Sep 2011 - Dec 2013
Director Quality Assurance Molecular Imaging
Ge Healthcare
May 2005 - Sep 2011
Regulatory Affairs Director
Hospira
Mar 2004 - May 2005
Project Manager, Pmp
Abbott
Mar 1983 - May 2004
R and D Project Manager
Education:
Winona State University 1976 - 1981
Bachelors, Bachelor of Science
Skills:
Iso13485, 21Cfr820, 21Cfr Subchapter J, Team Leadership, Mentoring, Regulatory Affairs, Regulatory Submissions, Quality System, Quality Assurance, Medical Devices, Molecular Imaging, X Ray, Fda, Fda Gmp, Positron Emission Tomography, Design Control, 21 Cfr, Quality Auditing, V&V, Regulatory Requirements, Hardware Diagnostics, Validation, R&D, Iso 13485, Capa, Cross Functional Team Leadership, Six Sigma, Ce Marking, Gmp, 21 Cfr Part 11, Quality Management, Dmaic, Iso 14971, Process Improvement, Change Control, Research and Development, U.s. Food and Drug Administration, Verification and Validation, Business Process Improvement, Corrective and Preventive Action