Quality Assurance Customer Service

Karl Z. Svec

***** ***** **. **, **** Rapids, MN, 55433 ( 612-***-**** (

abssjm@r.postjobfree.com

Summary

** ***** ** ******* ** a quality assurance leader working in metrology and

avionics.

Demonstrated ability to create, implement, document, and oversee processes

and procedures structured to improve operations while maintaining customer

satisfaction and regulatory requirements.

Experience

Medtronic, Inc., Minneapolis, MN - Metrology Laboratory

2004-present

Global leader in disease management specializing in implantable biomedical

devices

Quality Application Specialist (2007 -present)

Responsible for the creation, improvement, validation, and documentation of

metrology processes used to calibrate equipment used in the development or

manufacturing of medical devices.

. Created or revised more than 90 processes used by technicians to

verify 2,500 pieces of equipment at 23 Medtronic facilities worldwide.

. Recognized for the design and validation of 34 automated procedures

used in the annual calibration of over 180 pieces of equipment,

reducing turnaround time by more than 80%.

. Successfully managed and audited the documentation of over 700 pieces

of software used to verify the integrity of over 5,500 pieces of test

equipment.

. Accomplished a critical validation of an upgrade to a master equipment

database, used by forty technicians and over 300 customers, to ensure

changes did not damage the integrity of the system.

. Served on guidance committees tasked with shaping and writing official

departmental policies for equipment management and laboratory

operations.

. Authored a departmental policy used to control working copies of

quality-critical spreadsheets to ensure conformity to regulatory

requirements.

. Collaborated with a development team to create the calibration process

for a next-generation medical device test system. Specifically,

authored twelve complimenting processes totaling over 100 pages of

work instructions dedicated to the assurance of compliance company-

wide.

Assistant Metrology Lab Supervisor (2005 - 2007)

Responsible for the day to day operation of the Electronic Metrology Lab;

managed technicians and support staff to ensure departmental goals and

quality requirements were met for over 8,500 pieces of equipment.

. Prioritized, directed, and assigned work to a team of 9 calibration

technicians to meet customer needs and regulatory requirements for

over 8,500 pieces annually calibrated equipment.

. Primary point of contact for the coordination of special projects,

priority work, and company-wide initiatives, earned the all-time

highest customer satisfaction score.

. Reviewed lab operations and methodology, revised quality assurance

forms to reduce paperwork burden by more than 50% while maintaining

compliance.

. Analyzed the qualifications of external vendors to accomplish

subcontracted Metrology work.

Senior Calibration Technician (2004 - 2005)

Provided calibration, troubleshooting, and repair of electronic test

and measurement equipment, covering a wide variety of disciplines, to

GMP, FDA, TUV, and ISO requirements.

. Independently performed the calibration, troubleshooting, data

analysis, and repair of over 1,100 pieces of test equipment.

. Created and modified calibration procedures to improve accuracy and

efficiency.

Thales Avionics, Edison, NJ - Avionics Shop

2001-2004

Multinational leader in flight avionics, supporting the Airbus commercial

fleet in the Americas

Lead Avionics Technician

Managed the end-to-end shop process for three avionics computers,

totaling more than 3,000 pieces of equipment, used on Airbus Jetliners

to ensure customer safety, product quality, and maximum shop

efficiency

. Won an innovation award for the creation of a troubleshooting database

which decreased turnaround time, improved customer service, and

increased repair reliability.

. Driven to quickly earn certifications for the test, repair, and

modification of eight avionics computers in accordance with FAA

regulatory requirements.

United States Air Force - Metrology Laboratory

1997 - 2001

ISO certified flight-line support calibration laboratory supporting the

northeast United States

Calibration Technician

Accomplished the calibration, alignment, repair, and modification of

test equipment to ensure mission readiness, aircraft systems safety,

and quality / regulatory compliance

. Accomplished full circuit of laboratory training encompassing all

major disciplines of metrology

Education

Master of Business Administration, GPA 3.92

Bethel University, St. Paul, MN, November 2010

Associates of Computer Science, GPA 3.89

North Hennepin Community College, Brooklyn Park, MN, August 2007

Bachelors of Science in Technical Management, Summa Cum Laude, GPA 4.0

DeVry University, Oakbrook Terrace, IL, October 2005

Associates of Applied Science in Electronic Systems Technology

Community College of the Air Force, Maxwell AFB, AL, 2001

Additional

. Permanent work authorization for the United States.

. Certified in Object Oriented Computer Programming and Internet

Programming, North Hennepin Community College, Brooklyn Park, MN, 2007

. Computer experience: Microsoft Office including Access, Visio, and

Publisher

. Software Experience: SAP, C, C#, C++, Visual Basic, Java, SQL, .NET,

LabView, LabWindows CVI

Professional Core Competencies

Quality Assurance ( Process Development ( Process Validation ( Process

Improvement ( Software Development ( Software Verification ( Test Plan

Development ( Priority Setting ( Customer Focus ( Communication ( Data

Analysis ( Database Administration ( Metrology ( Calibration (

Documentation ( Regulatory Compliance ( Research and Analysis ( Process

Coaching

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