Lourna Barnett is seeking a position as a Quality Systems/Compliance Officer. She has over 15 years of experience in quality and compliance roles in the medical device industry. Her experience includes developing and implementing quality systems, conducting investigations, and ensuring regulatory compliance. She is skilled in problem solving, project management, auditing, and data analysis. She holds multiple certifications from the American Society for Quality.

1. Barnett, Lourna
Lourna1@hotmail.com  33066 Merritt Road, Menifee, CA 92584 951.316.3056
OBJECTIVES
As a Quality Systems/Compliance Officer,I want to work with a growth oriented organization
where I can utilize my experience in the field of quality and compliance to identify compliance
issues and managing them effectively.
PERSONAL SUMMARY
I am an accomplished analytical thinker and passionate problem solver having the ability to
read and interpret complex regulations and make accurate operational decisions. I have a long
and successful track record of evaluating compliance issues within an organization and then
taking appropriate action to improve operational performance. I have the skills and abilities
necessary to develop and implement policies, procedures and programs that will ensure
compliance with existing regulations and best practices. I am customer oriented, motivated and
proactive and ready to take on new challenges. Currently looking for a position where I can
make a positive contribution and would ideally like to work for a company that has an inclusive
environment where employees have the opportunity to succeed.
SKILLS
Problem Solving/ Root Cause Analysis CAPA
Project Management Data Analysis
Science of Human Error GMP (Good Manufacturing Practices)
Human Error Investigation Change Control
QSR & Industry Practices Auditing
Quality Systems Calibration
Various International Standards FDA
EXPERIENCE
Abbott Vascular |Temecula, CA
Sr. Quality Systems Analyst/ Lead Investigator January 2006 – Present
Class III Medical Device Manufacturer (Implantable)
Accomplishments

2. Barnett, Lourna
  
 Developed and implemented the Exception Management Process, which consolidated
multiple exception processes into one.
 Developed, implemented, and maintains an effective training program designed to
maintain the CAPA system and quality system compliance.
 Developed and implemented a controlled process for the creation of numeric
Nonconformance codes (NC) used for classifying Nonconformance associated with
products/materials; Streamlined the existing NC codes; 240 codes into a manageable list
of 70 codes.
 Expanded Returned Goods analysis capability through capital equipment purchases
under the legacy VS business unit.
 Developed process for timely response to competent authority (Vigilance) inquiries.

Responsibilities
 Maintains compliance with applicable Regulations, Standards, Corporate and Divisional
policies and procedures.
 Leads CAPA investigations consisting of diverse cross-functional teams to ensure
adequate identification of quality issues and the appropriate correction and resolution of
those issues.
 Ensures investigations are written according to Divisional policy and site procedures.
 Utilizes statistical methodologies, problem solving tools, and techniques to ensure
thorough investigation of identified issues.
 Communicates to all levels of Management on all aspects of investigations to ensure
consistency and alignment.
 Promotes an environment of continuous improvement.
 Liaises as the CAPA SubjectMatter Expertto regulatory agencies.
 Develops implements and maintains Quality System procedures and systems.
 Assists with Corporate and Divisional metric reporting.
 Provides technical support for CATSWeb user base as well as support to IT with test
script execution.
ADDITIONAL EXPERIENCE
Int’l Rectifier HexFet America
Quality Systems/Failure Analysis Tech January 1999 – February 2006
Semiconductor Manufacturer
Accomplishments
 2005 Founders award recipient for efficiency improvements achieve through Lean initiatives.
 Developed and implemented a sustainable internal quality auditing program and
supported compliance to a variety of Quality System (i. e., ISO/TS16494, ISO/IEC17025,
ISO13485, ISO9001)
 Developed and Implemented sustainable processes including a Five S system,
laboratory safety training program, SPC and Gage R&R program, performance metrics,
Laboratory Process Control Plan, OCAP, and PFMEA.

3. Barnett, Lourna
  
 Streamlined reliability test data analysis process through development of validated
macros.
Responsibilities
 Data analysis and reporting for all reliability test protocols
 Supervised calibration of all inspection equipment, ovens, and chambers.
 Responsible for tracking worldwide CAPA activities for reliability-related incidents. Final
approval of effectiveness verification to close.
 Responsible for identifying and qualifying third party calibration service providers for test
chambers
 Calibrated and used a wide range of inspection tools and equipment.
Connor Formed Metal Products
Quality Assurance Tech October 1996 – November 1998
Metal Stamping and Spring Manufacturer
 Supervised calibration of all inspection equipment,ovens, and chambers.
 Responsible for development of standard operating procedures for implementation of
an ISO9000 compliant quality system.
 Responsible for document control, PPAP submissions, Certificate of Compliance,
supplier quality, and material verification.
 Developed and implemented a quality auditing program.
Quality Assurance, P & G Precision, Inc.
Jun. 1996 – Aug. 1996
Supplier ofMedical device hardware
 Responsible for maintaining calibrated measurement equipment
 Responsible for First Article inspection of tooling set up, machine capability and process
capability studies
 Audit
Quality Assurance, Medtronic, Cardiopulmonary Division
July 1995 – Jun. 1996
Class II Medical Device Manufacturer
 Line clearance
 First Article
 Final Inspection
 Nonconforming Material
Quality Assurance, Device for Vascular Intervention
February 1991 – July 1995
Class II Medical Device Manufacturer
 Final Inspection
 Responsible for Nonconforming Material disposition and scrap

4. Barnett, Lourna
  
 Responsible for maintaining Metrics
EDUCATION
Portland State University
2011 BS Criminology
 Honor Society Phi Kappa Phi
 Dean’s List
American InterContinental University
2009 AA Business Administration
 Honor Roll
 Dean’s List
PROFESSIONAL AFFILIATIONS
American Society for Quality
 Certified Quality Engineer (Cert No. 47541)
 Certified Quality Process Analyst (Cert No. 2)
 Certified Quality Technician (Cert No. 17372)
COMPUTERSKILLS
 Microsoft Office (Word, Excel, PowerPoint, Visio & Outlook)
CATSWeb by Assurx