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JENNIFER HERHOLD
JENHERHOLD@YAHOO.COM I 806-317-9238 I LINKEDIN.COM/IN/JENNIFER-HERHOLD
SENIOR QUALITY ASSURANCE ENGINEER
Quality Assurance Engineer for 6 years with an additional 3 years of experience in Software
Support in a competitive Medical Device company. Extensive background in Project
Management.
FDA 21 CFR Part 820 Root Cause Analysis
ISO 9001 and 13485 CAPA Systems
Program Implementation Internal and External Audits
Continual Improvement Document Control
PROFESSIONAL EXPERIENCE
Elekta,Inc 2007 – Present
Senior Quality Assurance Engineer, Lubbock, TX (Outlander) 2014 – Present
Quality Assurance Engineer, Lubbock, TX (Outlander) 2010 - 2014
Product Support Specialist, Henderson, NV 2007 - 2010
Product Support Coordinator, Henderson, NV 2007 - 2007
 Supervise, manage and perform Internal Audit Program including quarterly metrics.
 Act as Regional Document Control Supervisor
 Subject matter advisor to departmental, functional, and company management
 Ensure effective CAPA Program by managing open CAPAs and ensuring completion and
effectiveness
 Managed Calibration Program for Field Service Engineers
 Experience in validation testing
 Assign and perform employee training
 Analyze and lead process changes needed for organization development
 Regional Deputy Management Representative
Notable Achievements:
 Recognized for leading the successful implementation of new document repository (M-Files) for
my region.
 Lead harmonization effort for order fulfillment processes for new customer lifecycle management
system.
EDUCATION AND TRAINING
 Bachelor of Arts, Psychology, 2001 • Texas Tech University, Lubbock, TX
 ASQ Training for ISO, FDA , Root Cause Analysis, and 36 Hour Lead Auditor Training
 Model Manager Training Course for Presentation Skills, Remote Management, Assertiveness
Skills, Behavioral Interviewing and Coaching Skills
TECHNOLOGY SKILLS
Proficient in Excel, Word, Visio, Publisher, DocCompliance, M-Files, and SalesForce.COM.

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Resume 2016

  • 1. JENNIFER HERHOLD JENHERHOLD@YAHOO.COM I 806-317-9238 I LINKEDIN.COM/IN/JENNIFER-HERHOLD SENIOR QUALITY ASSURANCE ENGINEER Quality Assurance Engineer for 6 years with an additional 3 years of experience in Software Support in a competitive Medical Device company. Extensive background in Project Management. FDA 21 CFR Part 820 Root Cause Analysis ISO 9001 and 13485 CAPA Systems Program Implementation Internal and External Audits Continual Improvement Document Control PROFESSIONAL EXPERIENCE Elekta,Inc 2007 – Present Senior Quality Assurance Engineer, Lubbock, TX (Outlander) 2014 – Present Quality Assurance Engineer, Lubbock, TX (Outlander) 2010 - 2014 Product Support Specialist, Henderson, NV 2007 - 2010 Product Support Coordinator, Henderson, NV 2007 - 2007  Supervise, manage and perform Internal Audit Program including quarterly metrics.  Act as Regional Document Control Supervisor  Subject matter advisor to departmental, functional, and company management  Ensure effective CAPA Program by managing open CAPAs and ensuring completion and effectiveness  Managed Calibration Program for Field Service Engineers  Experience in validation testing  Assign and perform employee training  Analyze and lead process changes needed for organization development  Regional Deputy Management Representative Notable Achievements:  Recognized for leading the successful implementation of new document repository (M-Files) for my region.  Lead harmonization effort for order fulfillment processes for new customer lifecycle management system. EDUCATION AND TRAINING  Bachelor of Arts, Psychology, 2001 • Texas Tech University, Lubbock, TX  ASQ Training for ISO, FDA , Root Cause Analysis, and 36 Hour Lead Auditor Training  Model Manager Training Course for Presentation Skills, Remote Management, Assertiveness Skills, Behavioral Interviewing and Coaching Skills TECHNOLOGY SKILLS Proficient in Excel, Word, Visio, Publisher, DocCompliance, M-Files, and SalesForce.COM.