Jim A Lipka

1859 Mohawk Dr, Lancaster, OH 43130

Medical Devices

Jim Lipka LLC - Minneapolis since Sep 2012
CEO & Senior Consultant
Terumo Cardiovascular Systems - Ann Arbor, MI since Sep 2012
Consultant - Validation Engineer II
Medtronic - Mounds View, MN Oct 2007 - Jun 2012
Principal Reliability Engineer
Medtronic - Mounds View, MN Nov 2006 - Oct 2007
Principal Quality Assurance Engineer
Abbott Laboratories - Abbott Park, IL 2002 - 2006
Quality Assurance Manager - Level 2

Columbia University in the City of New York 1977 - 1982
PhD, Chemistry Columbia University in the City of New York 1976 - 1977
MA, Chemistry University of Michigan, Ann Arbor, MI 1972 - 1976
B.S.C., Chemistry & Cellular Biology

Capa
Quality Assurance
R&D
Internal Audit
Iso 13485
Fda
Design Control
Medical Devices
V&V
Quality System
Iso 14971
Validation
Design of Experiments
Gmp
Change Control
Black Belt
Gdp
Regulations
Manufacturing Operations Management
Post Market Surveillance
Spc
Failure Analysis
Cross Functional Team Leadership
Root Cause Analysis
21 Cfr Part 11
Dmaic
Glp
Process Improvement
Testing
Six Sigma
Iso
Quality Control
21 Cfr
Manufacturing
Sop
Gamp
Software Documentation
Product Development
Fmea
Process Simulation
Computer System Validation
Minitab
Quality Management
Quality Auditing
Biomedical Engineering
Gxp
Supplier Quality
Regulatory Affairs
Ce Marking

English

Lancaster, OH