Medtronic - Medtronic CardioVascular since 2011
Pr. Software Quality Engineer
Medtronic CardioVascular - Brooklyn Park, MN Apr 2007 - May 2011
Sr. Software Quality Engineer
Medtronic Cardiovascular Oct 2001 - Mar 2007
Software Quality Engineer
Datacard 1998 - 2001
Software Test Engineer
Education:
MS Software Engineering
Skills:
Quality System Iso 13485 Medical Devices Design Control Capa Fda V&V Testing Design of Experiments 21 Cfr Part 11 Regulatory Affairs Minitab Quality Assurance Iso 14971 Cross Functional Team Leadership Validation Six Sigma Biomedical Engineering Dmaic Fmea Quality Control R&D 21 Cfr Quality Management Corrective and Preventive Action Gmp Software Quality Root Cause Analysis U.s. Food and Drug Administration Medical Software Biotechnology Software Documentation Auditing Capital Equipment Product Launch Manufacturing Engineering Software Development Iso Failure Analysis Software Validation Software Engineering Iec 60601 Iec 62304 Spc Software Project Management Software Quality Assurance Supplier Quality Verification and Validation
Interests:
Children Education Disaster and Humanitarian Relief
Certifications:
Iso 13485 Lead Auditor- Quality Certification Iso 13485