KENNETH R. ZABEL

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

Niles, MI **107

608-***-****

ad1yuq@r.postjobfree.com

A high energy, resourceful, Quality Engineering and Compliance Management Professional - a creative problem solver; enables manufacturers of automotive, heavy equipment, aerospace, commercial food equipment, medical devices, and others to achieve competitive edges and maintain high quality standards. Quality Management, Social Compliance, Health & Safety Auditor; prepare or review PPAP, IQ/OQ/PQ validation and supplier qualification reports. Developed and expanded the Global Food Equipment Sanitation Certification Programs (commercial food equipment against NSF/ANSI public health safety standards) at NSF International, Intertek/ETL Semko, and CSA International.

EDUCATION

ISO 9001:2008 Lead Auditor Training - SAE; ISO 9001:2015 Transition - MRA, Caliso; AS9100D - BSI

B.B.A., Quality Management Cum Laude, Cleary University, Ann Arbor MI

Honors Biology Program, University of Michigan, Ann Arbor MI

PROFESSIONAL EXPERIENCE

GREAT LAKES METAL STAMPING, Quality Manager 8/2023 to 11/2023

Manufacturer of metal stamped parts, providing weldments and assemblies to diverse markets - automotive, appliance, agricultural, consumer, furniture, heavy equipment, industrial, recreational, power tools. Supplier Quality Auditor, Internal Auditor - IATF 16949, ISO 9001:2015. Developed Layered Process Audit (LPA) and Product Audit Programs.

TATA CONSULTANCY SERVICES (TCS) PRODUCT STEWARDSHIP ENGINEER 7/2021 to 7/2023

Johnson & Johnson – Ethicon: RoHS and REACH compliance of surgical staplers, adv. energy 7/2021 to 12/2022

devices, robotic surgery, clip appliers, and trocars used in minimally invasive and open surgical procedures.

RoHS Subject Mater Expert (SME): Directives 2002/95/EC, 2011/6/EU, 2015/863

REACH Review Substances of Very High Concern (SVHC): 1907/2006 - Annex XIV, XVII

Safe Drinking Water and Toxic Enforcement Act of 1986 (CA Prop 65) compliance validation

Material of Concern (MOC) Data collection (review) from suppliers, contract manufacturers

Ethicon R&D Materials, Biocompatibility & Stewardship Team; Restricted Sub. Mgmt. (RSM)

Johnson & Johnson MedTech Product Stewardship Team

QUALITY/SAFETY COMPLIANCE EXPERT (contractor) 2011 to 2012; 2014 to 2022

ISO 17025 Gap Analysis Audits: RoHS Testing Laboratory (A2LA Workplace Training AWPT)

APSCA Social Compliance Auditor – SMETA, SA8000 (Intertek, Bureau Veritas, QIMA, AI, UL) #21702305

Contract Auditing: Internal Audits, Supplier Audits (ISO 9001, AS9100, SA8000, SMETA, specific company specs)

SGS North America: Sustainability Auditor (AIAG Sustainability) – suppliers to Fiat Chrysler America (FCA); QMS Auditor (ISO 9001:2008) – suppliers to Mattel; Compliance Auditor – Samsung Appliance Service Centers

Speaker, Automotive Quality Management Conference (Novi, MI 2018): Benchmarking Audits of Suppliers to Identify Common Challenges & Lessons Learned in Applying New Standards (organized by Hanson Wade)

FDB Events: Design and present custom training on ISO 9001:2105 Quality Management and Social Management Systems at various global locations including Dubai and Kuala Lumpur

Zimmer Biomet (medical devices), Supplier Remediation (FDA 403 findings), IQ/OQ/PQ, Risk Assessments

SQA Services: QMS Auditor (ISO 9001:2008, AS9100C) – audit suppliers to SpaceX (rocket manufacturer)

Wacker Neuson (construction equipment): internal auditing upgrade to ISO 9001:2015 (STS Technical Services)

SAI Global : Certification/Compliance Auditor - North & South American manufacturers of plumbing fixtures, materials against NSF/ANSI 61, CSA B125, AS/NZS Water Quality Standards

Underwriters’ Laboratories - UL-STR Division: QMS Auditor (ISO 9001:2008); Product Verification & Validation (PV&V); Pre-production compliance assessments; inspections, evaluations

Fuji Electric Co (Coffee Making Equipment from Japan), Inacio de Castro Figueiredo food slicers from Brazil), Javar (meat grinders from Columbia): Coordinate certification processes with Certification Body (ETL, CSA, NSF, UL), train safety engineers to support certification against NSF, UL, CSA Standards

Miami Walk-in Coolers, CresCor (heated cabinets, refrigerators), GE Lighting (refrigerator lighting), F.A.C.E.M. SpA (food processing equip): write, update certification reports submitted to certification agencies (UL, NSF, CSA, ETL)

Reaction Housing (temp housing units): NFPA 70, 101, 1192 (NEC, National Fire Prot. Assoc.) compliance validation

Parker Hannifin (refrigeration filters, valves, components) ATEX 94/9/EC, 2014/34/EU [ATmosphères EXplosives]

TAYLOR EQUIPMENT, Senior Compliance Engineer, Rockton, IL 2012 to 2013 Manufacturer of soft serve ice cream makers/dispensers, double-sided grills, custom food equipment

Coordinated agency approvals - Electrical Safety (UL, ETL), Gas Safety (CSA/AGA), Sanitation (NSF), CE Approvals and IEC 60335-1 (TÜV Rhineland); assessed, coordinated NFPA, HACCP, RoHS, REACH, WEEE, ATEX Compliance

Internal Quality Systems Auditor, Trainer (ISO 17025 - SAI Global); Internal Lab Auditor (ISO 9001:2008 - UL)

CSA INTERNATIONAL, Certification Specialist Independence, OH 2005-2010

Global Third-Party Certification Body; Division of the Canadian Standards Association

Developed and expanded CSA Sanitation Program which included evaluation and documentation of commercial food equipment against NSF/ANSI public health safety standards; conducted combined Sanitation/Gas & Electrical Safety Certification projects. Trained, mentored Certification Engineers across North America, Europe, China.

Designed and conducted training for CSA Engineers from across North America, Europe, and Asia to conduct evaluations, test commercial food equipment and integrate the agency product safety certification and sanitation reports.

INTERTEK - ETL SEMKO, Sr. Sanitation Engineer Cortland, NY (home based in Michigan) 2003-2005

Global Third-Party Certification Body

Evaluated, tested, and documented compliance of commercial food and pool equipment - NSF/ANSI Public Health Safety Standards and conducted performance testing at clients' facilities; prepared/reviewed Safety (Gas, Electrical, Water) and Sanitation Certification Reports

Developed and conducted training in North America, Europe, Asia enabling engineers, auditors to also conduct evaluations; test commercial food, pool equipment against NSF/ANSI Standards; mentored/reviewed subsequent work.

BOSAL INDUSTRIES, Quality Engineer (two contractual positions), Warren, MI summers 2002, 2005

Manufacturer of automotive. aerospace exhaust systems, components.

Review & authorize Quality/Production Plans; DFMEA, PFMEA; Gage R&R

Prototype assessment & validation; PPAP Preparation, CMM use: PC-DMIS

Drove corrective actions and system enhancements to ensure compliance with ISO9002, QS-9000, TS/ISO 16949, AS-9000, and ISO 14001 standards; realized reductions of external defects (68%), internal scrap (7% to 1.5%).

FDA 21CFR Material Compliance Review – designed/managed new material review processes

SPIRAL INDUSTRIES, Quality Engineer (contractual), Howell, MI 2002

Manufacturer of hose and tube assemblies: automotive, truck, tractor, and aerospace customers

GD&T, CMM use, inspections of hose and bent tube products; complaint investigation, resolution, prevention

Implemented AS-9000 and TS/ISO 16949; DFMEA, PFMEA

MAPCO (Merchants Automated Products Co.), Quality Control Supervisor, Canton, MI 2001 to 2002

Precision machining, lathe, grinding of metal fabricated automotive, aerospace, medical device, and custom parts

Validate CNC set up, floor and first article inspections, final audits of custom milling, grinding metallic products; prototype runs for aerospace, automotive customers.

Supplier Quality Engineer, audited suppliers, contractors; PPAP, IQ/OQ/PQ Review

Procure Test and Inspection Gages; Geometric Dimensioning & Tolerancing; DFMEA, PFMEA; Gage R & R

Developed GD&T, SPC and QS-9000 training and document controls; audited suppliers, contractors

EXEMPLAR MANUFACTURING, Quality Control Laboratory Supervisor, Ypsilanti, MI 1999 to 2001

Manufacturer of fasteners: automotive, military, aerospace, medical industries; brake actuator assemblies

Performed QC testing of fasteners against ASTM standards for tensile strength, shearing, corrosion resistance.

Calibrated, repaired test equipment, calipers, micrometers, other gages; Gage R & R, APQP, PPAP preparation

Supplier Quality, reviewed quotations, Pre-Production Plans; validate CNC set up; CMM use (PC-DMIS)

Developed procedures, trainings to obtain ISO 9001 & QS-9000 registration, ISO 14001 & 17025 compliance

NSF INTERNATIONAL, Sr. Food Equip. Program Rep. Food & Pool Testing Group Leader, Ann Arbor, MI

Global Third-Party Certification Body 1989 - 1999

Evaluated, tested, tested, documented compliance of commercial food and pool/spa equipment

LABORATORY: Testing Group Leader; Safety Team Member/Auditor, Lab Safety Officer, Nuclear Safety Officer

CERTIFICATION (Program Representative): Evaluated equipment, worked with manufacturers to resolve non-compliance issues and obtain required documentation; trained, reviewed work of new employees

Created training and documentation guides to explain how food equipment is to be evaluated, tested, documented, certified, and compliance audited

Manufacturing, Certification, and Quality Trainings designed and presented by Kenneth R. Zabel

Analyze Data & Identify Root Cause

8-D Problem-Solving (Eight Discipline), or Global 8D, a step-by-step problem-solving methodology popularized by Ford Motor Company: Use Team Approach; Describe the Problem; Implement and Verify Short-Term Corrective Actions; Define and Verify Root Causes; Verify Corrective Actions; Implement Permanent Corrective Actions; Prevent Recurrence; Congratulate Team.

7 Step Problem Solving, a structured basis designed by Chrysler to help deliver outcomes and solutions to problems: Find the

Right Problems to Solve, Define the Problem, Analyze the Problem, Develop Opportunities, Select the Best Solution, Implement, Evaluate and Learn; designed by Chrysler Corporation,

5-Why Analysis - asking "Why?" five times, successively, to understand the ultimate root cause and complete a Cause & Effect diagram; designed by General Motors.

Unified Problem Solving Team. I designed and taught a combined problem-solving methodology which combines the 5-Why, 7 Step, 8-D, FDA 21CFR 820, and MIL Specification Processes to allow problems to be assessed and tracked at the same level for all manufacturing areas (GM, Chrysler, Ford, medical, and military) while at Exemplar Manufacturing.

Cost of Poor Quality (COPQ) quantifying negative outcomes due to waste, inefficiencies and defects in a process.

Regression Analysis - statistical measurement of correlation can be calculated (least squares method) to quantify the strength of the relationship between variables

Fishbone Diagram used to identify all of the contributing root causes likely to be causing a problem

Histogram graphs of a distribution of data designed to show centering, dispersion (spread), and data shape (relative frequency)

Design of Experiments to evaluate which process inputs have a significant impact on the process output

Statistics Handbook - to efficiently use statistical methods

Improve Processes

Brainstorming - in an atmosphere of suspended judgment - no criticism - so that ideas freely flow from the participants

Six Thinking Hats - when working towards a goal without a clear solution, change your hat, change your idea (perspective)

System Diagrams - study of the behavior of complex systems - seeking to understand the web of relationships between activities

Error-Proofing (poka-yoke) - implementation of fail-safe mechanisms to prevent a process from producing defects

6M’s (manufacturing): An organization defined as it transforms raw Material to products and services to serve the Market. Three key resources are used in this process – Manpower, Money, and Machinery/equipment. The sixth M stands for process Management.

6M’s (quality): Machines, Methods, Materials, Measurements, Mother Nature (Environment), Manpower (People)

Corrective Action Matrix is used by problem-solving teams to keep track of who is doing what - by when

Measure & Collect Data

Measurement System Analysis (MSA) to qualify a measurement system for use by quantifying its accuracy, precision, and stability.

Trend Chart (Run Charts) to show trends in data over time

Statistical Process Control (SPC) uses control charts used to plot data over time and identify both Common Cause variation and Special Cause Variation - establish control limits to detect an out-of-control or out-of-specification condition

Six Sigma Conversion Table - Defects Per Million Opportunities are converted to a Sigma Level - equivalent to 99.9997%

Define & Prioritize Problems

Failure Mode & Effects Analysis (FMEA) to prioritize potential defects based on severity, frequency, and likelihood of detection

Affinity Diagram to sort/consolidate a large amount of information into groupings (clusters of ideas); natural ‘affinities’

Pareto Chart (Manufacturing) shows the relative frequency of defects in rank-order

Pareto Chart (Service) to rank the various categories/causes of a problem

Process Flow Chart provides a visual representation of the steps in a process - Gives everyone a clear understanding of the process; Helps to identify non-value-added operations; Facilitates teamwork, communication; keeps everyone on the same page

Value-added Flow Chart to improve cycle times, productivity by visually separating value-adding, non-value-adding activities

Project Priority Calculator to identify those projects that have the highest priority.

Control Processes

Production Product Approval Process (PPAP) preparation, updating, review, approval processes; APQP, Control Plans, DFMEA, MSA, SPC, PFMEA

CHECK Process – a simple tool to evaluate process conformance (Correct, Housekeeping, Equipment, Contain, Keep doing it!)

Installation, Operation, Performance Qualification (IQ/OQ/PQ) of medical devices, including special processes which cannot be validated by other means; Risk Analysis of unvalidated processes, FDA 483 Letter Resolution

7S: Team Spirit, Safety (6S) added to 5S - workplace organization, housekeeping: Sort, Straighten, Sweep, Standardize, Sustain

Statistical Process Control (SPC) uses control charts used to plot data over time and identify both Common Cause variation and Special Cause variation and to establish control limits to detect an out-of-control or out-of-specification condition

Failure Mode & Effects Analysis (FMEA) used to prioritize potential defects based on their severity, expected frequency, and likelihood of detection - Design (DFMEA) and Process (PFMEA)

Advance Production Quality Planning (APQP), Design for Six Sigma (DFSS) - techniques used to develop products

11/30/2023

Contact this candidate