DOUGLAS JOHNSON

CERTIFIED QUALITY ENGINEER * CERTIFIED RELIABILITY ENGINEER

CERTIFIED QUALITY AUDITOR * CERTIFIED QUALITY MANAGER

ISO/QS 9000 LEAD AUDITOR * 6 SIGMA ASSOC. & KODAK BLACK BELT &

NQA-1 LEAD AUDITOR LEAN certified.

12096 Dogwood Street, Coon Rapids, Minnesota 55448

PHONE: 763-***-**** CELL: 612-***-****

Email: acugyp@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Skilled professional with multiple years of progressive background in Quality/Product Engineering, Plant Management.

* Developed and conducted effective programs adapted and still used at GRACO, SEAGATE, and KODAK.

* Excellent leader and motivator---successfully incorporated Management by Objective and Interaction, and

Management Concepts in the workplace.

* Demonstrated ability to set goals, prioritizes workloads, and meets objectives.

* Well-developed ability to define problems, devise and implement solutions.

* Extensive PC background. Expansive use of Quality Control software (Windchill, Doors, JMP, Mini-Tab, Relia-soft)

* Quadruple Certification: Quality Engineer; Reliability Engineer; Quality Auditor; Quality Manager;

* International background in Quality Systems (International Quality Auditor through the IQA, Geneva)

* Bachelor of Science in Physics

* MBA of Business Administration

* 6 Sigma Associates/Kodak – 6 Sigma BlackBelt trained and certified/Lean trained and certified to TPS.

* Listed in year 2000 Who's Who

Capabilities include the following:

- SPC/FMEA/GEOMETRICAL TOLERANCING/

BLUE PRINT READING Trainer - ISO 9000/QS 9000, 13485, 16949, 17035, 14971

- MIL Specs 45208; 45662, 9858; 275D; 429C - Design of Experiments –ANOVA/MANOVA

- GMP (Good Manufacturing Practices) - Regression Analysis -- DFMA -- DFSS

- Failure Mode & Effect Analysis (FMEA) - Hypothesis Testing

- Lean Manufacturing - Flex Gauging Programs – MSE/GR&R

- Audit Programs - Capability Studies (Machine

- MIL Spec Adaptation/NDT Processes) SPC -- DMAIC

- Total Quality Management Training - QIT (Quality Improvement

- Supplier Certifications - Teams)

- PWB, PCA, Rigid Flex background - Process Redefinition & Standardization

DOUGLAS JOHNSON

PROFESSIONAL

EXPERIENCE

Greatbatch Medical/Integer, Plymouth, MN. March 2015-Present

Principal Design Assurance Engineer

Design Assurance activities; including writing the Risk Management Plan and Report.

Guide the design team in the development of dFMECAs, uFMEAs, and pFMEAs for the FDA submission of the proto-type device.

In-depth work with the design team to bring the prototype-type device to market.

Development of several Design Verification Tests to verify critical to Design device features and characteristics.

Statistical analysis of all Design testing

Approval for compliance of all test plans, IQ/OQ/PQ plans, and design documents generated by other engineers in the Design department.

Conducted a gap analysis of all Design Assurance documents generated for compliance to ISO 14971:2012

American Medical Systems, Minnetonka, MN. May 2014 – March 2015

Senior Design Assurance Quality/Contract Engineer

Design Assurance activities; including writing the Risk Management Plan and Report for the Merit Stress Urinary Incontinence implant and delivery tool

Guided the design team in the development of dFMECA, uFMEA, and pFMEAs for the IDE FDA submission of the proto-type device.

Worked diligently with the design team to bring the prototype-type device to an In-Human Use readiness state.

Development of several Design Verification Tests to verify critical to Design device features and characteristics.

Statistical analysis of all Design testing – wrote white-paper regarding testing protocol required to prove design features and characteristics.

Conducted failure analysis, and authored report on findings, when packaging failed Design verification protocol

Approval of all test plans generated by other engineers in the Design department.

Conducted a gap analysis of all documents generated for the Merit PRIME project versus FDA and internal requirements.

St. Jude Medical, Minnetonka, MN March 2013 – April 2014

Senior Design Assurance Quality/Contract Engineer

Design Assurance activities; including writing the Quality and Risk Management Plan for the MediGuide 2.0 enabled products, and the newly developed Nano-stent. Leadless Pacemaker, following ISO 14971:2012 guidelines.

Development and authoring of test methods, test plans, Design Verification Tests, Design Validation Tests (DVT) and PDP activities.

Authored IQ, OQ, PQ, and PPQs for remediation activities.

Extensive development of GR&R and P/T ratios for all lab equipment (electronic and mechanical) as part of remediation/validation activities.

Approval of all test plans generated by other engineers in the Design department.

Electric Machine/WEG Minneapolis, MN Feb 2011- Feb 2013

Quality Manager/Sr. Engineer/Lead Nuclear & ISO Auditor

Complete responsibility for Internal Quality and Supplier Quality Programs, including the Approved Supplier’s Program and list (ASL).

Assess suppliers (nuclear and commercial) via supplier audits, Quality System Assessments, and internal metrics.

Assures Electric Machine’s compliance to 10CFR50 and 10CFR21, ISO 9000:2008, AWS D1.1 and ASTM welding standards as applicable, and ISO 17025.

Conducted internal and external audits following NUPIC, NIAC, ISO 9001:2008, ISO 17025, and AS9100 requirements the Lead Auditor.

Complete responsibility for the Corrective/Preventative Action (CAPA) and Material Review Board (MRB) programs.

Complete responsibility for Commercial Dedication program and nuclear programs.

Prepares bi-annual Quality Management Report and approves monthly Quality reports.

Prepares annual Nuclear Quality reports to Fairbanks Morse and Nuclear Regulatory Commission (NRC).

Writes, reviews, and approves internal Quality Procedures (QPs), material specifications, and drawing packages.

Maintain and manage a Global Quality program over several of WEG’s manufacturing sites around the world.

Leads efforts to train employees on Quality programs such as Lean and 6 Sigma initiatives to drive internal operating and scrap costs down.

Managed nine person Quality Department

Boston Scientific, Inc. Maple Grove, MN June 2008 – 2011

Sr. Supplier Quality Engineer/Manager 1

Plan and conduct scheduled assessments of suppliers to access compliance with Boston Scientific requirements. Includes assessment preparation meetings and scheduling in advance of site visit. Conduct and confirm follow-up actions on Supplier Quality Systems Assessments.

Assess supplier capabilities through direct visits, technical discussions and Quality System Assessments.

Prepare detailed trip reports and Assessment Reports to document assessment findings and observations.

Communicate quality issues to suppliers as needed and provide assistance to develop corrective actions.

Review, understand, and implement updates related to BSC Policy changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs.

Participate with Corporate and regional Supplier Quality organization on policy/procedure/guideline development. This includes generation, review, and implementation of these documents.

Generate Quarterly Supplier Performance Reports.

Track and trends supplier performance, taking remedial action as needed.

Interface with the Procurement Commodity Specialists.

Maintain accuracy of SAP Vendor Assessment Report and Supplier Profile Reports.

Provide guidance to Purchasing and Engineers in applying supplier quality system requirements. Provide project direction, coaching, and mentoring for engineers and technical team personnel.

Contribute and participate in supplier performance reviews.

Train suppliers, assessors, and other BSC personnel on QA specifications for suppliers.

Support the development of Supplier Quality infrastructure by working with management, as an effective leader, on the development and enhancement of critical processes and procedures, as well as training and mentoring less experienced staff.

Support the day to day activities that take place for activities related to Alliance partner products. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Provides leadership role on championing departmental and cross-functional engineering activities

Proactively investigate, identify, and implement best-in-class Quality Engineering practices.

Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Develop or enhance Quality Systems to lower over-all manufacturing costs utilizing the VIP system.

Core team member working directly with R&D engineers for the development of new products. Oversaw Quality responsibilities through each step of product development.

Responsible for validation and verification of new designs by writing Quality Plans for new components. Verified and validated new equipment, processes and procedures through the Installation Quality (IQ), Operational Quality (OQ) and Performance Quality (PQ) verification and validation steps per Boston Scientifics’ policies and procedures.

Used advanced statistical procedures (ANOVA and MANOVA) to determine the contributing amount of variable factor in a process to optimize the process. JMP, MiniTab and Crystal Ball software used for process analysis.

Responsible to verify measurement equipment was capable of measurements (10% or less of total tolerance) using Ford type GR&R along with Measurement Systems Evaluations (MSE) techniques.

Performed risk analysis on new components (either new designs or product enhancements) to determine overall failure risks/opportunities to the completed product, and make product life projections on durable goods.

Developed component test plans based on DHF and DFMEA. Developed accept/reject criteria based on identified critical features and customer requirements. Used WINDCHILL software to track ECO changes and associated test plan changes.

Worked directly with suppliers to develop PFMEAs, PokoYoking their processes, and enhancing their production process to increase yields.

Worked directly with internal manufacturing and suppliers to use TPS –Lean techniques and Kaizan events to optimize the processes, increase throughputs and reduce overall costs.

Conducted internal audits as the lead auditor to assure operations were following requirements of ISO 13485

Interfaced with Microbiology and Regulatory departments to assure EtO, steam, and Gamma radiation systems of product sterilization were meeting the requirements of ISO-10993, Part 1.

KODAK HEALTH IMAGING LAB. Oakdale, MN. May 2001-2008

Principal Quality Engineer/6 SIGMA BLACKBELT/LEAN MANUFACTURING BLACKBELT

Support New Products Development Teams throughout the commercialization process with supplier selections, data analysis, design inputs and design reviews following FDA requirements.

Incorporated DMAVD 6 Sigma techniques for new products.

Wrote Quality and Reliability plans for new products. Worked closely with Manufacturing Manager to develop the Manufacturing Plan and Product Acceptance plans.

Principal QA Engineer for 8200, 8250, 6800, and 8900 format medical laser imagers.

Lead SPOT teams in Calibration Systems enhancement activities, cost reduction activities, and current product piece part improvements. This totals over $1,500,000.00 in cost saving activities to Kodak in the 2001-2002 timeframe. Acted as 6 Sigma Project Lead for a lens improvement project that resolved a major quality concern for Kodak Health Imaging.

Strategic Quality planning, development of test criteria, procedures, and timelines, implementation of test plans internally and at testing labs, data analysis, and documentation of results in KHI database. Wrote test standards for material interactions and shipping tests to be used in testing all new products.

Developed component test plans based on DHF and DFMEA. Developed accept/reject criteria based on identified critical features and customer requirements. Used DOORS software to track changes as products developed and through revision changes.

Monitored and developed remote monitoring systems. Made corrects to the imagers remotely and collected data for product enhancements.

Visited installation sites to gather Voice of Customer data and became the customer advocate to the Design teams. Data was used for product and feature enhancements to new designs and existing imager formats.

Used DMAIC principles to discover major material interaction issues within an optics module, which lead to an interdivisional product enhancement activities and ECO changes.

Mentored other Kodak engineers in BlackBelt techniques, data analysis, and planed DOEs.

Sold the idea of, and coordinated DFMA training at Oakdale Labs with Rochester Strategic Quality Group. Current DFM Software principal.

Assisted in the identification of better equipment and lab measurement techniques for analysis of lens quality.

Conducted internal audits as the lead auditor to assure operations were following requirements of ISO 13485.

HONEYWELL INTERNATIONAL, INC. Golden Valley, MN. 1997- March 2001

Sr. SUPPLIER QUALITY ENGINEER/6 Sigma BlackBelt

International Supplier development through part and supplier certification, accomplished by site visits, Product Management plans, Yield Data analysis, Process Charting, BlackBelt and SPC analysis, and DOE.

Site audits both internally and at international suppliers. Lead ISO/QS-9000 Auditor.

BlackBelt and Cost Reduction projects accomplished by following BlackBelt format of activities.

Support of New Product Development Teams with Supplier Quality data.

Liaisons between Honeywell and international suppliers, hands-on involvement with projects and process improvements.

Assist in the evaluation, selection, and certification of commodity suppliers. Identify, explore, and implement new technologies related to assigned commodities. Assist suppliers in the resolution of product issues. Serve as a liaisons between H&BC plants and assigned suppliers

Support Sub-contract group in the identification, selection, and certification of assigned sub-contractors.

Verify that Corrective Actions taken to resolve NCARs are reasonable and effective.

Supported Honeywell’s plants in Germany, Ireland, China, Mexico, and Singapore.

SEAGATE Technologies, Bloomington, MN, 1992 - 1997

Sr. SUPPLIER QUALITY ENGINEER

Verified and assured that piece parts supplied to Seagate, met or exceeded print requirements,

on an ongoing basis, throughout a worldwide supplier base.

Developed and implemented Supplier Part Qualification Plans, as a means to drive suppliers to assurance that parts met print requirements and were functional.

Used various engineering tools (SPC, FMEA, DOE, QFD) to verify and drive ongoing compliance by international suppliers.

Served as a resource personnel, to Seagate, as an expert in the commodities supported. Commodities supported were; machined parts, injected and thermal formed plastics, rubber moldings, metal extrusions, adhesives, labels, hardware, printed circuit boards, printed cable circuits, and PWB/PCC assemblies.

Responsible for supplier evaluations, supplier project management, quality planning, qualification of tooling, testing and processes, standards development and implementation, and internal ISO audits.

ISO-9000 certified Lead Auditor. IQA certified. Seagate’s Twin City Operation’s non- management representative and lead auditor. Served as the initial Project Manager to

implement ISO-9000 into Seagate Twin City Operations.

Networked directly with Far East and European Supplier Quality Engineers, for assurance that

parts designed by Twin Cities Operations continued to meet Seagate print functionality

requirements, as product was brought up in overseas sources, and through the transfer of the

product to Seagate’s Far East manufacturing sites.

Served as commodity expert in the identification of new suppliers on Supplier Development

Teams throughout the world.

Supported Far East operations in China, Singapore, Malaysia, Thailand, Indonesia, and Japan from IPO office in Shinagawa-ku, Tokyo. Lived in Kamakura, Japan for 2 years.

PROFESSIONAL GRACO, INC., Minneapolis MN, 1986-1992

EXPERIENCE QUALITY ENGINEER/QUALITY CONTROL/AUDIT SUPERVISOR

As a Quality Engineer:

Developed inspection techniques, gage design, SPC planning and analysis, failure analysis and

corrective actions, and Design of Experiments.

Planned and administered audits and Quality Function Deployment programs.

Installed gage control systems. Conducted machine and process capability studies.

Developed and initiated a vendor certification program.

Oversaw Quality Improvement Team activities and provided staff Quality Engineering support to standard product.

As the Supervisor of QC/QA -- Incoming, Assembly & Machining Inspection:

Hired, trained and supervised 32 inspectors, 8 Quality Engineers & 2 Procurement Quality Engineers.

Provided SPC training. Established Total Quality Management, and MRB activities.

Identified, documented, and controlled non-conforming material.

Provided Manufacturing with calibrated quality audit equipment and gauging.

Provided resource management, budget control, SPC training, development coaching for personnel and appraisal/measurement systems of the department and personnel.

Conducted Cost of Quality Analysis.

Reduced scrap from $800,000 to $200,000 over a 4 year period.

Supported Operation Desert Shield/Storm via build of tow behind grease-rack trailers in Abu Dhabi, UAE.

WRICO STAMPING, Plymouth, MN 1984 - 1986

QUALITY CONTROL MANAGER/MANUFACTURING ENGINEER

As the Quality Control Manager:

Managed quality programs and activities at all of Wrico’s plants nationwide. Directly

supervised 7 inspectors in Wrico’s Minneapolis plant.

Directed MRB, audited/qualified vendors, and administered supplier improvement.

Performed sales, sales support and customer liaison functions.

Served as Inspection Auditor and Procurement Quality Administrator.

As a Manufacturing Engineer of K-Tek’s assembly lines:

Developed manufacturing methods, fixturing, feasibility studies and labor standards.

Installed equipment and systems. Estimated long run tooling and assembly jobs.

Brought plants up to MIL-I-45208 and MIL-STD-45662. Wrote QC manuals to cover MIL

specifications and vendor qualification programs. Implemented SPC and SQA systems.

Set up Wrico as JIT vendor to Toro, John Deere, Caterpillar and Pitney Bowes.

Received awards of excellence from IBM, Burroughs and Pitney Bowes.

Set up ongoing training programs for SPC and blueprint reading.

Reduced scrap from 3.1% of sales to .3% in two years.

EDUCATION & UNIVERSITY OF MINNESOTA, Minneapolis, MN

PROFESSIONAL Bachelor of Science in Physics, 1974 – Transfer credits from UCA

DEVELOPMENT

AUGSBURG COLLEGE, Minneapolis Minnesota

BA of Business Administration, February 2009 - Management emphasis

Member of Alpha KI -- Magna Cum Laude

ARGOSY UNIVERSITY, Minneapolis, Minnesota

MBA – October 2012 -- Magna Cum Laude

ARGOSY UNIVERSITY, Minneapolis, Minnesota

Doctorate of International Business – writing disseration

Member of Sigma, Beta, Delta.

ASQC (American Society of Quality Control) - senior member

Certified Quality Engineer * Certified Reliability Engineer * Certified Quality Auditor * Certified Quality Manager

Certifications: ISO 9000:2008 & 13485 certified Lead Auditor. Nuclear certified Lead

Auditor (NIAC) to 10CFR50, 10CFR21, NQA-1, appendix B and epris 5652, 6406, & TR-102260.

6 SIGMA ASSOCIATES

BlackBelt and Lean Mfg. (Additional Lean Mfg. Training through Allied Signal)

Honeywell 6 Sigma BlackBelt certified.

Kodak 6 Sigma BlackBelt certified. Kodak Lean BlackBelt certified – Toyota Production System.

ITT - Chicago

Certified Orange Belt, Microsoft 2010 Project Manager

ST.PAUL TECHNICAL VOCATIONAL INSTITUTE, St. Paul MN.

ASEE - Course work in Basic Electronics, Semi-conductors, Analog, Digital,

Microprocessors and Laser Technology

NORTH HENNEPIN VOCATIONAL-TECHNICAL INSTITUTE

Supervision 1, 11 and 111

SOUTH HENNEPIN VOCATIONAL-TECHNICAL INSTITUTE

Die Design

GRACO, SEAGATE, KODAK, & BOSTON SCIENTIFIC INTERNAL TRAINING

Interaction Management; Quality Management; Negotiation Skills; Drug Abuse; Sexual Harassment; Presentation Skills; Excel, Word, Visio, Lotus Notes, World Web, Office XP Professional, Certified Process Improvement Manager (Kodak).

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