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Quality Assurance Manager

Location:
Elm Grove, WI
Salary:
86000
Posted:
October 30, 2014

Contact this candidate

Resume:

Louis W. Poggenburg

e-mail: acgj4q@r.postjobfree.com

**** *** *****

Cell: 414-***-****

Kenosha, WI 53144

OBJECTIVE: To obtain a challenging position as a Quality Professional

where I can apply statistical techniques for cost reduction,

regulatory compliance and for continuous improvement.

EDUCATION: BS Business Administration with Production/Operations

Management concentration

California State University, Hayward, CA 1999

EXPERIENCE:

Moxness, Mfg., East Troy, WI

Mar 13 - current Quality Assurance Manager/Engineer

1. Responsible for development of Class Six medical grade

silicone molded and over-molded parts for the medical

device [ISO 13485 compliance], aerospace [AS9100C

compliance] and automotive [TS16949/ISO9001 certified]

industries. Major customers include Eaton, Honeywell,

InControl Medical, Zirc Medical, Johnson Controls, Hewlett-

Packard, TE Connectivity, Deltrol and Pentair.

2. Implemented a renewed QMS system for AS9100C, TS16949/ISO

9001, Internal Auditing and 8D Corrective Action/Escape

point detection program.

3. Managed Quality Lab using CPs, PFMEAs, SPC/CpK, APQP and

PPAP protocols.

4. Initiated continuous improvement programs, including Cost

of Quality reduction, including 6? applications for scrap

reduction, and cGMP, and RMA elimination.

5. Responsible for the management of continuous improvement

and special projects, regarding risk analysis, ISO

compliance and new product launches.

6. Developed a 5S program and assumed special projects under

the direction of the Chief Operating Officer.

7. Responsible for company training of production improvement

and QA activities.

General ThermoDynamics, Franklin, WI

Mar 12 - Feb 13 Quality Assurance Manager/Franklin & Iron

Ridge, WI

8. Responsible for development of Supplier Quality Assurance

and Customer end user requirements in thermal heat

transfer units. Major customers include Caterpillar,

Cummins, Hitachi and Manitowoc.

9. Implemented PPM and 8D Corrective Action programs

10. Managed Quality Lab department and cost reduction through

Rework/Scrap Operations.

11. Responsible for the management of continuous improvement

and special projects, regarding risk analysis, ISO

compliance and new product launches.

12. Implemented Continuous Improvement (5S, VSM, single-piece

flow, Kaizen) events and production flow process

standardization.

13. Assumed special projects under the direction of the

company President.

Acme Machell, Inc., Waukesha, WI

Sep 10 - Nov 11 Quality Assurance Manager/6 Sigma Engineer

14. Responsible for development of Supplier Quality Assurance

and Customer end user requirements in rubber and silicone

molding for the automotive industry. Major customers

include FTE, Harley-Davidson, and Kongsberg Automotive

groups.

15. Implemented Six Sigma /Lean Operation Kaizen events, using

DOE and other multivariate methods. Engaged in physical

testing and specification test activities, to include

Statistical Process Control.

16. Managed Quality and Lab department staff, engaged in

molding process support, and cost reduction through

Rework/Scrap Operations.

17. Responsible for the management of continuous improvement

and special projects, regarding risk analysis, production

part approvals, TS/ISO compliance, and other new product

launches.

18. Assisted in Lean Manufacturing implementation. (5S, VSM,

single-piece flow, Kaizen) events, Continuous Improvement

and production flow process standardization.

19. Assume special projects under the direction of the company

VP.

Allis-Roller LLC. Franklin, WI

Aug 06-May 09 Quality Assurance Manager

20. Responsible for development of Supplier Quality Assurance

GMPs and Customer requirements in the metal fabrication

and machining industry.

21. Managed the Quality Department staff to include hiring,

performance evaluations, and SOP development.

Transitioned to Lean Manufacturing Practices.

22. Developed prototype operations and product releases for

OEM engineering/production with Case-New Holland, John

Deere, Putzmeister, Waukesha Engine and Vilter.

23. Actively pursued continuous process and quality

improvement as measured by internal indices and external

audits/reports.

24. Responsible for the management of continuous improvement

training regarding risk analysis, production part

approvals, TS/ISO compliance, and warranty operations.

25. Responsible for disposition on all raw materials,

components and finished goods.

26. Assisted in Lean Manufacturing implementation. (5S, VSM,

single-piece flow, Kaizen) events, Continuous Improvement

and production flow process standardization.

27. Assume special projects under the direction of the company

CEO.

MD Support, Inc., Pleasanton, CA

Oct 02-Jul 06 Project Manager

28. Responsible for maintaining medical billing compliance

with regulatory requirements for HIPPA, Blue Cross/Shield,

Medicare and Medicaid SOPs, using MS Project.

29. Developed company-wide marketing program and managed

Medical Billing department.

30. Responsible for the training of CPT and ICD-9 Medical

Coding.

31. Managed QA functions using Medisoft, Lytec, and MedPlexus

software programs.

Sterigenics (IBA), Hayward, CA

Sep 01-Oct 02 Quality Assurance Manager

32. Quality management representative responsible for

maintaining quality management system for medical device,

biomedical, and pharmaceutical industries, as well as

compliance with regulatory requirements for the 21CFR820,

ISO 13485, FDA, NRC, USDA, EPA, DEA, and OSHA in the

Radiation Sterilization Industry.

33. Actively pursued continuous process and quality

improvement as measured by internal indices and external

audits/reports, GMP and SOP development.

34. Coordinated activities for global 8-D corrective actions

and process improvements.

35. Executed process validations, calibrations, reports, and

dose mapping protocols.

36. Worked with sales and plant personnel in developing

customer relationships, problem resolution, process

initiatives, and providing outstanding customer service.

Oct 99-Aug 01 Finelite, Inc., Hayward, CA/ Pro-Tek Mfg.,

Livermore, CA

Quality Assurance Manager

37. Responsible for Quality Control of Supply Chain for 50

different suppliers ranging from steel and electronic to

plastic components. Sheet metal processing included

receipt of cold roll steel coils/sheets, laser cutting,

press break forming, progressive die

forming, stamping, bracket welding/fabrication, and

painting.

38. Developed and implemented Quality Assurance programs and

SOPs for ISO 9002 preparation; w rote ISO Operations

Manual and Quality Assurance Manual.

39. Developed Documentation Structure and outlined Policies,

Standard Operating Procedures, Logs/Forms, and QA

Manufacturing work instructions.

40. Established Company wide Data Collection and Analysis

Program with cross-functional engineering projects using

Six Sigma training.

41. Implemented Standardized Work and Process Control

Monitoring Systems.

Plastikon Industries, Inc., Hayward, CA

Dec 97-Oct 99 Quality Engineer \ ISO Coordinator

42. Certified Internal Auditor ISO 9000; completed 3

Surveillance Audits.

43. Managed company wide Calibration and Corrective Action

Program.

44. Responsible for Quality of 100 different products using

APQP/PPAP for QS-9000

45. Assisted in the Implementation of the "Toyota Production

System".

46. Involved in a "Just In Time" Manufacturing System with New

United Motors Manufacturing and Toyota Motors

Manufacturing of Canada.

47. Developed various Designs of Experiments for Injection

Molding.

48. Implemented Standardized Work, Process Control Monitoring

Systems.

49. Working knowledge of Process Capability Studies, First

Articles, and Process FMEAs.

Mar 96 -Apr 98 California State University-Hayward;

Hayward, CA

Lecturer/Teaching Associate

50. Lecturer for Quantitative Analysis (#3100) / Operations

Research (#6100).

51. Topics covered include: Mathematical Programming (Linear,

Integer, Dynamic, 0-1, and Goal), Sensitivity Analysis,

Queuing Analysis, Discrete Event Simulation, Markov Chain

Analysis, Project Management, Network Analysis,

Transportation Models, Scheduling\Assignment Models,

Decision Analysis, Inventory EOQ Models, Distribution

Statistics, Probability, Data Analysis, and Random

Processes.

COMPUTER

SKILLS: . MS Project . GPSS Simulation . VISIO .

ABQM /POM

. SPSS . SAS . Minitab . QSB+ .

SQL/Access

Certification Six-Sigma Green Belt, Harley-Davidson - November

2011

Internal Auditor, TS16949 re-certification - November 2013

Internal Auditor, ISO9001 re-certification, Caliso 9000 -

November 2011

Military Non-Commissioned Officer, US Air Force - Honorable

Discharge, Aug 84 -Aug 88

Currently in 115th ANG - Madison, WI (Truax field/ Dane

Co. Airport) 16 yrs.



Contact this candidate