Christy Lynn Kowalewski

Quality Assurance Manager at Tucson Embedded Systems Inc., Quality Consulting & Auditing at Consultant

Tucson, Arizona Area

Computer Software

Tucson Embedded Systems Inc. since Nov 2009
Quality Assurance Manager
Consultant - Tucson, AZ since Jan 2007
Quality Consulting & Auditing
Kimberly-Clark Jan 2004 - Dec 2008
Quality Associate II
Kimberly Clark Jan 2002 - Apr 2007
Environmental Coordinator
Kimberly-Clark Healthcare Jul 2001 - Dec 2003
Quality Associate I

Quality Systems
ISO 13485
Software Validation
CAPA
FDA
ISO
ISO 14001
GMP
Quality Assurance
Quality Management
Compliance
Continuous Improvement
Medical Devices
21 CFR Part 11
cGMP
Change Control
Root Cause Analysis
Documentation
Microsoft Office
Internal Audit
Quality Auditing
Metrics
AS9100
DO178B
Software Quality Assurance
Quality System

Spanish

4911 east Broadway Blvd, Tucson, AZ 85711

Health, Wellness And Fitness

ScriptSave - Tucson, Arizona Area since May 2013
Manager of Quality Systems
Consultant - Tucson, AZ since Jan 2007
Quality Consulting & Auditing
Tucson Embedded Systems Inc. Nov 2009 - May 2013
Quality Assurance Manager
Kimberly-Clark Jan 2004 - Dec 2008
Quality Associate II
Kimberly Clark Jan 2002 - Apr 2007
Environmental Coordinator

Quality System
Quality Assurance
Capa
Quality Management
Iso 13485
Fda
Medical Devices
Validation
Process Improvement
Continuous Improvement
Quality Auditing
Iso
Testing
Dmaic
Root Cause Analysis
Software Documentation
Six Sigma
Sop
Internal Audit
Quality Control
Auditing
21 Cfr Part 11
V&V
Lean Manufacturing
Program Management
Iso 9000
Iso 14001
Gmp
Change Control
Microsoft Office
As9100
Quality Systems
Software Validation
Documentation
Metrics
Do178B
21 Cfr
Do 178B
Corrective and Preventive Action
Standard Operating Procedure
U.s. Food and Drug Administration
Compliance
Cgmp
Software Quality Assurance
Certified Quality Manager/ Organizational Excellence

Spanish

Tucson, AZ