David L. Wisel

***** ******** **** ******* . **** Wayne, IN. 46845

Phone: 260-***-**** Email: abmgcr@r.postjobfree.com

Cell: 260-***-****

Operations Management Executive

Results-oriented, progressive leader with experience in domestic and

international operations, expertise includes; quality assurance, lean

manufacturing, and supply chain management. Visionary executive

responsible for strategic planning, P&L management with experience driving

profitability and growth within rapid-change environments. Proven ability

to analyze key business drivers and develop strategies that expand the

bottom-line. Successful in building mutually rewarding relationships with

suppliers and customers, implementing technological solutions to improve

quality, productivity and profitability while delivering on customer

commitments.

Areas of Expertise

Quality Assurance & Quality Control

Theory of Constraints

Budget & capital project management

Military, UL & CSA standards

ISO 9000, AS9100 & ISO/TS-16949

Zero Defect Programs

Extensive Multi-plant experience

Statistical Process Control

Supplier development

Strategic Business Planning

Business Process Kaizen

P&L Management

Supply Chain Management

IT Strategy & Execution

Mistake Proofing / Poka-Yoke

Dimensional & Testing Laboratories

RoHS & WEEE Compliance

Toyota Production System

Project Management

Total Quality Management

Internal & Supplier Auditing

Cross functional team facilitation

Safety & environmental compliance

Lean & Six Sigma

Training & Staff development

MRP & ERP implementation

NAFTA compliance

Selected Achievement / Highlights

* Development and implementation of quality system and Lean Sigma

efforts; for several organizations with multi-site locations. My

efforts led to a reduction in delivered defects of 87%, customer

complaint processing went from an average of 24 days to an average of

three days and we achieved 100% compliance to our 24 hour containment

and customer notification requirements. Eliminated dependence on in-

line inspection by promoting mistake-proofing techniques and operator

responsibility for quality. The activity reduced the quality staff

from 15 to six, resulting in a reduction of quality costs to less

than 5% of gross sales while reducing delivered PPM defects 87%.

* Implementation of quality system that achieved ISO 9001, QS-9000,

ISO/TS-16949, ISO 13485 and FDA 21 CFR (part 820) in as little as six

months. Served as Management representative within the various

quality systems over the past 20 years, specializing in paperless and

paper light systems. Enhanced supply chain management system

including; Supplier Quality Manual, scorecard reporting system and

onsite development activities, results included a 60% reduction of

incoming inspection activities and a dramatic increase in on-time

delivery.

* Fully proficient with both basic and advanced quality techniques;

Thorough understanding of the "seven basic quality tools" SPC,

Regression Analysis, Cause-and-effect-diagrams etc. Knowledge of DOE

Design of Experiments along with the use of multiple software tools

including Minitab. Fully versed in all aspects of metrology

including plate, CMM layout and 3d non-contact scanning. Proficient

with gauge design, calibration and R&R.

* Supply chain management; comprehensive domestic and specializing in

off shore "hands on" supplier development throughout Europe, Asia,

India and Mexico. Extensive experience in supplier tracking

techniques, sourcing, auditing, setting objectives and driving CI in

the supply chain. Experience with returnable packaging and extensive

product testing knowledge. Thorough knowledge of MRP & ERP systems.

* Cross functional team management. Regularly lead new products team

and Kaizen events. Facilitated projects that supported Y2K

compliance, RFID, inventory management / scheduling system, MRP and

ERP systems, BPK Business Process Kaizen, custom solutions that

solved chronic business problems in gauge calibration, preventive

maintenance, customer complaints and non-conforming material

tracking, inventory control and scheduling accuracy. Nearly 15 years

experience in Senior Management leadership using a policy deployment

process to established business objectives, reduce overhead expenses,

strengthen product gross margins, overhaul operating processes,

resolved quality / warranty issues, improve work environment and

increase moral.

* 25 years of "hands on" experience, in the following processes: FRP

molding Injection molded plastics, Wire harness fabrication, assembly

& soldering, thermoforming, rotation molding, injection molding, blow-

molding, metal stamping, CNC Machining, fabrication, Die Casting,

fixture design, gauge design, packaging design, painting, plating and

extensive automated assembly line experience.

* Trainer and Facilitator of all aspects of the Toyota Production

System including: Lean sigma, ZQC zero defects quality control, value

steam mapping, Poka-yoke, standard operations, MDI, policy deployment

/ senior management leadership. My efforts led to a nomination for

TBM enterprises "Perfect Engine" award as one of the top lean

companies in North America.

Professional Experience

Quality Manager -- Smiths Medical, Multi-National Medical December 2009 - Present

Device Manufacturer

Responsible for establishing and maintaining the quality/regulatory systems

conforming to FDA Quality System regulations and other foreign regulatory

agencies. Additionally responsible for ISO 9001, 21 CFR Part 820, ISO

13485 in compliance with the Medical Device Directive producing respiratory

and Tracheostomy class II devices. Successfully revised our customer

complaint investigation and CAPA systems. Conduct Risk Reviews and DFMEA

activities to assure consumer safety and protect company interests.

Instrumental in 510k projects including design verification and validation

activities on three new products. Developed and implemented a plant wide

GMP training initiative for all plant personnel that was eventually adopted

throughout Smiths Medical. Supplier development and improvement is a focus

of my position. The company selects projects based on VAVE and solves

chronic issues utilizing six sigma techniques. A focus on personnel

development for existing associates and recruitment of two quality

engineers has finalized my current role with the company.

Quality Manager -- Group Dekko, 12 locations in Midwest, Juarez December, 2008 -

Mexico, China and Alabama November, 2009

My responsibility included managing the quality system for five locations,

serving as Management Rep for ISO 9001, ISO/TS-16949, ISO 13485, AS9100 and

FDA 21 CFR Part 820 for class I medical devices. Processes include; wire

harness assembly, automated assembly, soldering, stamping, injection and

rubber molding. Revised CAPA corrective and preventative action systems

within our medical device facility and utilized similar tools within our

automotive and appliance facilities. Developed a supplier quality

management system to assess current suppliers, qualify new suppliers and

developed an online supplier portal. Responsible for RoHS, WEEE, UL & CSA

compliance programs including documentation and audits as applicable.

Worked with a team to improve the functionality/productivity of test

benches and testing associates. Another primary focus was to move from a

culture of inspection to auditing and to provide production operators with

the tools to be responsible for quality through Mistake proofing our

processes. Working with the supply base and receiving personnel to reduce

or eliminate non-value added and costly incoming inspection. Participating

as a core team member responsible for the successful launch of medical

device for KAZ, labeled under the Braun division of Proctor & Gamble.

Responsible for new product development of a quality system to comply with

AS9100, ITAR and other systems regulations for military applications.

Professional Experience

Quality Manager -- Gold Shield Inc., 5 locations in NE Indiana, April, 1997-December,

Mexico & Southern California 2008

Developed the companies quality system and documentation to support

certification in QS-9000, ISO 9001:2000 and compliance to ISO/TS 16949, ISO

13485, ISO 14001, FDA 21 CFR (class I medical devices) and OSAS 18001

serving as the management rep for each location. Provided daily leadership

for each location and traveled extensively between Indiana and Southern

California to assure company / quality objectives and profits were

satisfied. Responsible for the dimensional and testing laboratories

including CMM layout and failure mode analysis. Directed the internal

audit team that reviewed / reported compliance with corporate, ISO 9000,

supplier, customer, SOX, quality assurance requirements and tracked

progress via a CAPA escalation system.

Implementation / facilitation of the Toyota Production System with

experience in all aspects of Lean and expertise in Policy deployment, ZQC,

rapid program launch, APQP, problem solving teams, quality mapping, lean

sigma and BPK kaizen events. Member of an extremely independent general

management team responsible for establishing company objectives, P&L,

kaizen steering activities, QS/ISO management review and weekly system

status reporting to comply with internal objectives and corporate financial

expectations. Led cross-functional Policy Deployment teams to improve

quality, increase productivity, improve supplier performance, increase

sales and reduce cost. Implemented a customer complaint database system in

compliance to CAPA requirements, a daily cross-functional material review

board process, a paperless ISO/QS-9000 document control and retrieval

system to enhance failure mode analysis and facilitate problem solving.

The results of my efforts include:

. Safety - Improved 85% in the past five years, measured by accidents

per 100 associates.

. Quality - Improved 87% from FY 2000-FY 2006, measured as delivered PPM

rejects.

. Cost - California operations achieved profitability for the first time

in seven years due to our efforts. Increased operating income by

$350k during the first fiscal month of FY 2009, annual goal $800k

. Delivery - Days of raw material down 46%, finished goods inventory

down 66%

. Moral - Reduced associate turnover 75% during FY 2007

. State of Indiana Quality Improvement Award - Winner 1999

. Supplier of the year Award - Honda, Spartan Motors and Newmar

. 2008 Perfect Engine award nominee - Awarded to the top lean companies

in North America

. Hired, trained and developed Quality Assurance teams for each location

. Created quality systems from infancy to full registration in less than

one year.

Director of Quality -- EMF Corporation, 7 locations in NE January, 1995-April,

Indiana & Southeastern US 1997

Directed the QS-9000 efforts of the company and achieved compliance in 13

months. Developed and managed the quality assurance and business efforts

for seven facilities with 18 direct reports producing wire harnesses and

oxygen sensors for various industries. Managed the IT group including Y2K

compliance and the implementation of a new ERP system for the organization.

Responsible for compliance to UL, CSA requirements including documentation

and audits. Responsible for the dimensional \ test laboratories and sample

production programs. Led a team to improve the functionality /

productivity of test benches and testing associates.

. Developed supplier tracking system

. Improved internal scrap and rework systems, refined ECN process.

. Assisted in the launch of two facilities from location selection to

the initiation of production

. Ground up development of policies, procedures, instructions and forms

to support QS-9000 system

. Led the company to QS-9000 and ISO 9001: 1994 compliance in 13 months

Additional Experience (prior to 1995)

Quality Manager, Quality Engineer, Supervisor, CMM Tech, Lab Tech and

Quality Auditor (detailed info available upon request)

Customers served

Ford, GM, Chrysler, Toyota, Honda, Trane, Carrier, True, Tyler, Copeland,

Manitowoc, Beverage-Air, Royal Vendors, GE Medical, Phillips Medical,

Allied Signal, Delphi, Caterpillar, Cummins, Detroit Diesel, John Deere,

Ingersoll Rand Delco Remy, Fleetwood, Winnebago, Coachman, Newmar, Thor,

International Truck & Engine, Hino Motors, Freightliner, Utilimaster,

Spartan Motors, Thomas Built Bus, MCI, US Department of Defense, Kawasaki,

Polaris, Bombardier

Education

BS in Business Management - Bellevue University, Bellevue NE. Dean's list,

graduated Summa Cum Laude 3.96 GPA

MBA - Ashford University, Clinton Iowa March 2009, graduated high honors

with a 3.89 GPA

Masters of Science Quality Assurance - California State University,

completion date April, 2012

Professional affiliations and Certifications

ASQ - Certification: (CMQ/OE) Manager of Organizational Excellence, (CQA)

Auditor & (CQT) technician

Lean & Six Sigma - Trainer and Management Champion

RAB Lead Assessor ISO 9000:1994

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