Supply Chain Quality Systems

JOSEPH J. HAEFNER

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

Baraboo, WI 53913

608-***-**** cell

*************@*****.***

QUALITY SYSTEMS PROFESSIONAL

I have a dual MSIE from the University of Wisconsin – Madison in quality systems management/engineering and applied statistics. As a post-MSIE graduate student, I taught design of experiments and statistical process control statistics in the College of Engineering.

As a quality systems manager, engineer, and statistician, my combined projects have generated in excess of $200,000,000 improvement value within one year of projects’ completion. The projects involved a broad array of products such as the initial launch of automotive air bags and variable cam timing. Improvement or new design launches of other products using APQP or IQ/OQ/PQ includes gears, electronics, tires, injected molded parts, chemical batch processing, tooling, active suspension assemblies, batteries, and hundreds of automotive, medical, and commercial products. My work also includes applied statistics for reliability assessment, risk/sample size, measurement, capability, and process control. During my career, I have completed hundreds of process qualification/improvement projects. This includes qualifying entire supply chains for international automotive markets.

My work has been within the regulatory environments of ISO 9001, ISO 13485, ISO 14001, IEC 60601, 21 CFR Part 820, and ISO 14971 risk assessment. My work hase corrected long-standing deficiencies inhibiting product realization and impeding the manufacturing of precision automotive and medical components and devices. This includes conducting product development for Ford, GM, Caterpillar, Mercedes, Volvo, and Chrysler using APQP, statistical designed of experiments, statistical analysis, and applied statistical modeling. I have also conducted reliability modeling for various components and assemblies.

RECENT PROFESSIONAL EXPERIENCE

Mallinckrodt (Contract Completed Sept, 2023)

-Statistical analysis

-Measurement equipment validation

-Supply chain product validation

-New product launch documentation

opFMEA

oAssembly instruction

oFunctional testing

Medtronic Enterprise Excellence (PXA) – Retired

-Production process engineering

-Litigation prediction model development

-6 Sigma/Lean trainer and coach

-Internal statistical consulting

-COS/MSO trainer

Other Companies:

Terumo Perfusion - Statistician

Modeled perfusion blood flow for FDA Consent Decree

JM Huber – Quality Director

Standardized multi-plant quality systems

Resolved production throughput problems

Mentored 6 Sigma candidates

Uniroyal – Quality Manager

Qualified supply chain and manufacturing for initial launch of automotive airbags.

Rayovac – Senior Engineer

Resolve production throughput issues

Managed key suppliers

Husco – Quality Manager

Qualified variable cam phasing supply chain to German automotive

0 PPM rejects in 6 months from launch

Conducted FMEA for automated production

Established supply chain process control plans

United Gear – Director of Quality

Resolved production quality issues

Established quality control system

K-Tek – Director of Quality

CAPA’d and resolved over 200 open issues

Double profit margin via reduced defective product

Credit Union National Association – Quality Administrator

Improved in every area of the Malcolm-Baldrige criteria via Policy Deployment

SKILL SET SNAPSHOT

Management:

Total Quality Management

Policy Deployment (strategic planning)

ISO 9001, ISO 13485, Malcolm-Baldrige, ISO/TS,16949

IEC 60601

Supply Chain Quality Management

Lab Management, Destructive/non-destructive Testing

Engineering Management of Improvement

Cost of Quality Reporting

Product Realization, APQP, PPAP

Systems Auditing

21 CFR cGMPs Parts 210, 211, & 820

Tactical Deployment of Quality

Quality Philosophy – Deming/Juran/Grant

Japanese Management of Technology

7 Management and Planning Tools

Development of Complex Systems

Hoshin Kanri

Statistician:

Regression Analysis

Response Surface Methods

GRR, Capability,

DOE, Classic and Taguchi

Reliability Modeling

Nonparametric Methods

Hypothesis Testing

Nonparametric Regression

Qualitative Quantitative Research Methods

Exploratory Factor Analysis

Arrhenius equation life cycle modeling

Six Sigma:

6 Sigma Trainer

DMAIC, DFSS

Transactional 6 Sigma

Value Stream Mapping, Lean

Facilitation of Multiple Teams

Six Sigma Master Black Belt

6 Sigma Champion/Steering Committee

Industrial Engineering:

Facilities Planning

Group Technology

Cellular Manufacturing

Kaizen

Human Factors Engineering

Engineering Management of Continuous Improvement

Engineer:

New Product Development

Reliability testing

Concurrent Engineering

Process control, SPC, defect reduction

7 Step Improvement Process

Process efficiency

7 Quality Control Tools

Process mapping

Failure Mode and Effects Analysis

Risk Assessment, PFMEAs

Metrology

Corrective actions, CAPA

6/7/8 D Corrective Actions

Quality Function Deployment (QFD)

New product qualification

Engineering management for globally competitive goods and services

EDUCATION

Master of Science: Quality Systems and Industrial Engineering/Applied Statistics

University of Wisconsin – Madison, WI 1995

ABD: Engineering Management Walden University, 2013

PUBLICATIONS

Numerous published articles.

CERTIFICATIONS AND AWARDS

RIT/USA Today's Quality Crystal for significant improvement in quality

Wisconsin Quality Network Award presented by Governor Tommy Thompson

6 Sigma Master Black Belt

Certified ISO auditing

Prior Senior Member ASQ

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