Technician Quality

Mark G. Wollenberg

** ******** ***** 716-***-****

Depew, NY 14043 *******@***.***

Professional Summary

R& D Technician and two-time "Visionary of the Year" nominee for

outstanding contributions with thirty years of progressive quality and

technical support experience. Background encompasses:

. R&D Modeling . ISO Quality Auditing/Systems .

Technical Writing

. Graphing/Trend Analysis . System/Equipment Qualification .

Project Management

. Product Life Testing . Design of Tests/Experiments .

Destructive Analysis

Results focused technical professional possessing exceptional

communication, teamwork, analytical, conceptual, and applied problem

solving skills. Excellent math aptitude; completed educational courses.

Professional Experience

Contract Pharmaceuticals Limited, Buffalo, NY

2007 - 2009

Maintenance Coordinator & Buyer/Scheduler

Administrated computerized systems for creating, updating and closing work

orders and reports related to mechanic operations. Met with Cell Leaders to

understand priorities and preventative maintenance requirements. Scheduled

maintenance work on a 3 shift 24 - 7 basis ensuring supplies met work

demand in the appropriate time frame. Scheduled PM work orders for all site

equipment and facility support. Evaluated material needed and purchased MRO

supplies to satisfy production requirements while balancing cost and

inventory considerations. Investigated and resolved invoicing & goods

receipt issues with Accounts Payable and Warehouse Receiving. Collaborated

with Maintenance and suppliers with respect to equipment and materials

specifications. Organized maintenance shop, parts and equipment storage.

Ordered for production maintenance and created Purchase Orders through the

SAP System as the plant backup MRO buyer.

. Modified an existing PO Requisition form with drop down boxes to

automatically input vendor, G/L account and cost center information

which improved productivity and accuracy.

Wilson Greatbatch Ltd., Clarence, NY 1976 - 2007

Technician - LVAD (2006 - 2007)

Welding LVAD assemblies and the final closures of the LVAD implantable

heart pump. Coordinated the calibration of equipment for the Drug Pump and

LVAD programs. Member of the Safety Team. Performed internal Quality audits

for ISO 13485 certification

R&D Technician - Modeling (2002 - 2006)

Created and set up new test matrices requested by customers. Performed

regular updates of data, including routine plotting and analyses to write

technical reports. Created a master schedule for all R&D Modeling tests

that require pulsing. Maintained Excel plot workbooks for R&D and customer-

driven studies. Assisted in developing a quality system for the Modeling

Team by creating and maintaining validation analysis workbooks for

different cell models. Provided technician support of the Drug Pump

Assembly and Test project by assembling, modifying and calibrating testing

apparatus, creating test methods/procedures, forms and documents. Conducted

experiments and test pumps. Assisted in the creation and calculations of

the test performance workbook, including graphs.

. Part of Drug Pump Team that received a bonus for the successful

transition of the P321 Program to customer's facility in California.

This team also completed research/analysis that mitigated the risk of

a $300 million lawsuit.

. Nominated for "Visionary of the Year" as part of Advanced Model

Development Group that developed modeling data analysis addressing

issues for critical customers (Guidant & St. Jude).

. Member of the Hot Cell Team that responded to potentially dangerous

situations involving "hot" batteries. Investigated/diagnosed root

causes and implemented corrective actions.

Mark G. Wollenberg

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. Created several Macros in Excel workbooks improving productivity and

accuracy of data gathering and analysis.

. Received a SPOT Award for discovering errors and discrepancies that

were pervasive in the R&D testing data files.

. Received a SPOT Award for hard work and dedication in support of

resolving an issue with the Guidant M2000 cell.

Quality Technician II - Li-Ion Batteries (1999 - 2002)

Installed Formation and Life Test systems and supported the calibration,

repair, validation, qualification and maintenance of the test systems.

Managed the placing of cells on Formation, Life Test, and radiographic

testing. Created production summary reports, historical databases and

graphs for critical formation data for each lithium ion model, and analysis

of rejects and questionable cells. Performed internal Quality audits for

in-house and the ISO audit. Performed Destructive Analysis on batteries.

Assisted in the qualification of new equipment/systems at the Capacitor

Division.

. Installed new Bitrode Life Test System and created cycling programs

for all applicable scenarios.

. Created work instructions/testing programs for lithium ion

Formation and Life Test processes.

. Nominated for "Visionary of the Year" creating a purchasing checklist

that reduced the cost involved in the purchase of equipment.

Technician II/Team Leader - Capacitor Program (1999)

Assembled prototype capacitors and wrote procedures and specifications for

assembly and production. Designed and performed experiments. Collected and

evaluated data to write engineering reports. Supervised and trained

assemblers on 3rd shift. Maintained the Formation Tanks and other chemical

mixtures used for production testing by cleaning, replacing, testing the

chemicals and adjusting to the proper levels daily.

Technician II (1994 - 1999)

Performed both destructive and nondestructive testing on commercial,

medical and prototype cells for quality and safety. Collected, interpreted,

and analyzed data to produce clear concise reports on said findings.

Coordinated activities and testing between Bell and Wehrle facilities.

. Offered recommendations that led to reductions in testing cycle times

and implementation of safer testing practices.

. Successfully set-up and performed non-routine testing without any

written procedures on several prototype cells.

Technician I (1988 - 1994)

Coordinated, set up, and performed performance testing on production

and experimental Drug Delivery devices and components. Performed

Reliability testing utilizing radiographic equipment, electrical and

fluid testing apparatus. Performed engineering evaluations,

qualifications and product life testing. Analyzed and documented

returned goods. Assembled Drug Delivery devices utilizing microscopes.

All responsibilities performed in a Clean Room.

Data Technician Inspector (1980 - 1988)

Senior Test Rack Assembler (1976 - 1980)

Education

Bryant & Stratton Business Institute, Buffalo, NY

Basic Electronics & D.C. Circuits (4.0 GPA), Electronic Technology Division

ERIE COMMUNITY COLLEGE, Williamsville, NY

Technical Math (4.0 GPA) & Statistics (4.0 GPA)

Professional Development

ISO 13485 Internal Auditor Certification, 2007

Internal Auditor Certification, 2001

CQT - Certified Quality Technician (ASQ), 2006

Introduction/Intermediate/Advanced Excel, 2000

CQPA - Certified Quality Process Analyst (ASQ), 2006 ISO 9000

Awareness Program Training, 1993

Radiographic Training, 2001 Quality

Education System Training (Crosby), 1992

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