Quality Assurance Product

Roger A. Morneweck

***** ***** ***** **********, **** 44230

Telephone 330-***-****; Email *****.*********@*****.***

OVERVIEW

Highly motivated, results driven, six sigma green belt, Senior Manager of Quality Assurance with proven quality experience who: successfully keeps production processes monitored, product quality at good performance levels and monitors quality system key performance indicators to ensure product quality is maintained; manages quality engineers, inspection technicians performance reviews; monitors all suppliers to ensure incoming material traceability and certificates of conformance are provided to comply with ISO and FDA audits.

EXPIERENCE

RICOH 3D FOR HEALTHCARE Cleveland, Ohio March 2023 – Present

SENIOR MANAGER OF QUALITY ASSURANCE

Responsible for the facilities product quality in accordance with ISO 13485:2016 & Title 21 CFR Part 820 quality standards.

Managing the day-to-day activities of quality inspectors and shipping personnel.

Review and approve incoming material, monitoring product quality using Statistical Product Control (SPC), monitor Key Performance Indicators (KPI), monitoring and approving Corrective Action Preventive Actions (CAPA), monitoring and approving Nonconformances (NC), instituted new quality part inspection process using a 3D scanner for printed 3D anatomical models.

Responsible for the quality manual, document control, procedures, work instructions, inspection plans, quality training, issuing a Certificate of Conformance for products, record keeping, machine maintenance program and calibration of tools.

Performed internal audits to evaluate the quality system performance and review of non-conforming product.

Conduct supplier reviews & supplier risk assessments to approve new suppliers.

METALCRAFT SOLUTIONS/ ACRO TOOL & DIE Akron, Ohio May 2022 – October 2022

QUALITY MANAGER

Responsible for the facilities product quality in accordance with ISO 9001:2015 & ISO 13485:2016 quality standards.

Managing the day-to-day activities of quality inspectors and shipping personnel.

Review and approve incoming material, monitoring product quality using Statistical Product Control (SPC), monitor Key Performance Indicators (KPI), issuing Corrective Action Requests (CAR) and using the Five Whys tool to determine root cause, instituted new quality part inspection plans for all new customer parts.

Responsible for the quality manual, document control, procedures, work instructions, inspection plans, quality training, issuing a Certificate of Conformance for products, record keeping, machine maintenance program and calibration of tools.

Performed internal audits to evaluate the quality system performance and review of non-conforming product.

Conduct supplier reviews & supplier risk assessments to approve new suppliers.

MEDTRONIC Minneapolis, Minnesota - (Contract Work) December 2019 – July 2021

SUPPLIER QUALITY ENGINEER SENIOR

Responsible for product quality across several medical product programs, including supplier designed products and Medtronic designed parts / assemblies.

Working with the Medtronic Records Control System (MRCS) to document Neuro Design History Files (NDHF), Agile to document product quality records, TrackWise to document Non-conformances and SAP to document quality activities.

Working to the Code of Federal Regulations: FDA 21 CFR part 820 Quality System Regulation, ISO 13485:2016 Quality Standard and ISO 9001:2015 Quality Standard.

Review and approve supplier Equipment / Installation Qualification, Operational Process Qualification, Perform DOE Qualification (IQ, OQ & PQ) process validation submittals, Review Gage R&R and TMV reports, review supplier Process Failure Modes and Effects Analysis (pFMEA), document Supplier Design Transfer Reviews (SDTR), process Supplier Change Requests (SCR), monitoring product quality using Statistical Product Control (SPC), monitor Key Performance Indicators (KPI), issuing Supplier Corrective Action Requests (SCAR), using Fishbone diagrams, using the Five Whys tool or DOE to determine root cause and participate in the Change Review Board (CRB) as an active member.

Using Minitab software to evaluate supplier product qualification inspection results.

Working with the Medtronic Supplier Change Request Portal and Zoom meetings to follow supplier product activities.

Conduct supplier reviews to evaluate production capabilities and supplier risk assessments.

ALSTOM Hornell, New York October 2018 - August 2019

SUPPLIER PRODUCT QUALITY DEVELOPMENT ENGINEER – Electrical Products

Responsible for supplier product quality across several passenger train & bus line programs, including supplier designed products and Alstom designed parts / assemblies.

Working to develop new very large multi-control harnesses with over 5000 connection points, Printed Circuit Boards (PCB) and electrical control cabinets for the Next Generation High Speed Train for AMTRAK.

Working to the International Railway Industry Standard (IRIS) and ISO 9001:2015 Quality Standard.

Review and approve supplier Advanced Product Quality Planning (APQP) submittals, review process pFMEA reports, document Supplier Design Transfer Reviews (SDTR), using Statistical Product Control (SPC), monitor Key Performance Indicators (KPI), issuing Supplier Corrective Action Requests (SCAR), using Fishbone diagrams, using the Five Whys tool, DOE to determine root cause and participate in the Change Control Board (CCB) as an active member.

Working with the Alstom Quality Portal and SAP to track and document program quality activities.

Conduct supplier reviews to evaluate production capabilities and supplier risk assessments.

PHILIPS HEALTHCARE Highland Heights, Ohio - (Contract Work) November 2016 – October 2017

SUPPLIER QUALITY ENGINEER III

Responsible for supplier product quality across several medical instrument programs, including everything from commercial-off-the-shelf (COTS) to custom made medical parts.

Working to the Code of Federal Regulations: FDA 21 CFR part 820 Quality System Regulation

Review and approve supplier Advanced Product Quality Planning (APQP) submittals, review process pFMEA reports, document Supplier Design Transfer Reviews (SDTR), using Statistical Product Control (SPC), monitor Key Performance Indicators (KPI), issuing Supplier Corrective Action Requests (SCAR), using Fishbone diagrams, using the Five Whys tool or DOE to determine root cause and participate in the Change Review Board (CRB) as an active member.

Working with Agile, Rational ClearQuest and SAP to track and document program quality activities.

Review drawings in Pro E and using WindChill to track and document drawing creation & changes.

HARRIS CORP. / EXELIS, INC. Fort Wayne, Indiana & Clifton, New Jersey - (Contract Work) March 2015 – July 2016

QUALITY ASSURANCE ENGINEER SENIOR

Responsible for supplier product quality across several space flight programs, including everything from commercial-off-the-shelf (COTS) to custom made aerospace parts.

Working to the following military standards: MIL-STD 130, MIL-STD 411, MIL-STD 461, MIL-STD 462, MIL-STD 808, MIL-STD 810, MIL-STD 826, MIL-STD 850, MIL-STD 975, MIL-STD 980, MIL-STD 1553, and MIL-STD 1773.

Inspect electronic Printed Circuit Boards (PCB) and electrical assemblies to the following standards: IPC J-STD-001, NASA-STD 8739.1, NASA-STD 8739.2, NASA-STD 8739.3, NASA-STD 8739.4 and NASA-STD 8739.5.

Extensive experience with supplier product development during source inspections, Statistical Product Control (SPC), issuing Supplier Corrective Action Requests (SCAR), using Fishbone diagrams, using the Five Whys tool or DOE to determine root cause and working closely with suppliers to develop their products to ensure they meet the product specifications.

Review and sign off on First Articles Inspections (FAI) per the AS9102 quality management system and document quality findings using TIP QA.

Travel to supplier locations to conduct process audits to ensure there are adequate checks in place to control quality assurance, and to conduct First Articles Inspections (FAI).

LOCKHEED MARTIN MST Akron, Ohio February 2008 – August 2014

SUPPLIER QUALITY ASSURANCE ENGINEER SENIOR/ LEAD QUALITY ENGINEER

Responsible for supplier product quality across several aircraft platforms, including everything from commercial-off-the-shelf (COTS) to military aircraft parts and manage the supplier quality team.

Working to the following military standards: MIL-STD 130, MIL-STD 411, MIL-STD 461, MIL-STD 462, MIL-STD 808, MIL-STD 810, MIL-STD 826, MIL-STD 850, MIL-STD 975, MIL-STD 980, MIL-STD 1553, and MIL-STD 1773.

Work with all functional areas from program management, engineering, finance, and subcontracts, to develop statements of work (SOW), product specifications, technical kick offs, production design reviews (PDR), critical design reviews (CDR), test readiness reviews (TRR), and acceptance testing procedures (ATP).

Review and approve drawings in PRO E using WindChill to track and document drawing creation & changes.

Working with Rational ClearCase, Rational ClearQuest, Rational DOORS, IBM CAS AD and SAP to document quality.

Extensive experience with supplier product development during source inspections, Statistical Product Control (SPC), issuing Supplier Corrective Action Requests (SCAR), using Fishbone diagrams, using the Five Whys tool or DOE to determine root cause and working closely with suppliers to develop their products to ensure they meet the product specifications.

Review First Articles Inspections (FAI) per the AS9102 quality specification and extensive quality inspection experience.

Experience developing new product DFMEA reports and process pFMEA reports to evaluate new product development.

Lead auditor for internal quality audits and mentor new hires as they participate with quality audits.

Travel to supplier locations to conduct process audits to ensure there are adequate checks in place to control quality assurance, and to conduct acceptance testing while developing product discrepancy test reports to inform program management of product limitations and / or nonconformance reports.

ALCOA / HOWMET Dover, New Jersey - (Contract Work) February 2005 – December 2007

QUALITY ASSURANCE ENGINEER

Responsible for product quality of aircraft turbine blades and vanes for Pratt & Whitney and Rolls Royce aircraft engines.

Work with all functional areas from program management, engineering, finance, and subcontracts, to develop new products to design specifications, using critical design reviews (CDR) and develop product DFMEA reports.

Work with production lines to develop LEAN manufacturing processes to minimize waste and develop new work procedures.

Extensive experience with supplier product development during source inspections, Statistical Product Control (SPC), issuing Supplier Corrective Action Requests (SCAR), using Fishbone diagrams, using the Five Whys tool or DOE to determine root cause and working closely with suppliers to develop their products to ensure they meet the product specifications.

Work with production to ensure product quality and help with source inspections of manufactured products.

GRADALL / JLG New Philadelphia, Ohio - (Contract Work) June 2004 – January 2005

NEW PRODUCT DEVELOPMENT TEST ENGINEER

Develop testing to support the development of new Agricultural Tele-Handlers to ensure each machine would meet or exceed the performance specifications developed by the engineering design team.

Install strain gauges for structural testing Tele-Handlers and develop new product endurance testing.

Work with cross-functional teams and participate as an integral team member.

NASA GLEN RESEARCH CENTER Cleveland, Ohio - (Contract Work) March 2003 – July 2004

DEVELOPMENT ENGINEER

Check engineering drawings in Pro E and provide detailed design manufacturing support working to NASA-STD 8739.1, NASA-STD 8739.2, NASA-STD 8739.3, NASA-STD 8739.4 and NASA-STD 8739.5.

Lead manufacturing teams from conception through final build of the Combustion Integrated Rack (CIR) used to train astronauts for missions aboard the International Space Station (ISS).

Machine small parts engineering developed using various machine shop equipment (mill, lathe, and drill press) to reduce procurement times and overall part costs.

THE GOODYEAR TIRE & RUBBER COMPANY Akron, Ohio January 1997 – June 2002

DEVELOPMENT ENGINEER

Develop new tires and follow existing tire lines in the Latin American Region for the Replacement Light Truck Tire Team.

Generate cross-section drawings using CAD, tire build specifications for light truck tires and tire Mold shapes in Catia.

Train new hires to the QS 9000 / ISO 9001 Quality Standards as the acting department representative.

Develop new quality procedures and develop quality presentations to inform management as well as the department of quality system changes. Use the APQP process for product planning, process development, and product validation.

Develop auditing schedules, lead internal audits, and Six Sigma Green Belt certification.

ABC DISPENSING TECHNOLOGY Akron, Ohio January 1995 – December 1996

RESEARCH & DEVELOPMENT ENGINEER

Create new and innovative beverage dispensers.

Generate schematics and drawings of beverage equipment using Auto CAD.

Design and evaluate quality testing of dispensers to find potential problems before the product is released to the field.

Lead project teams on various dispenser programs from product conception through initial product release.

Present beverage demonstrations to customers, investors, and stockbrokers to generate business and working capital.

AIRCRAFT BRAKING SYSTEMS Akron, Ohio January 1991 – May 1994

INSTRUMENTATION SPECIALIST ENGINEER

Develop and install electronic instrumentation for destructive and non-destructive testing of aircraft wheels and brakes.

Install accelerometers for vibration analysis of aircraft wheels, brakes, axles, and strut assemblies.

Perform load deflection testing on aircraft wheels, axles, and brake housings.

Instrument and conduct temperature studies on aircraft wheels, axles, and brakes.

EDUCATION

UNIVERSITY OF AKRON Akron, Ohio

Bachelor of Applied Science Degree in Mechanical Engineering Technology

STARK STATE TECHNICAL COLLEGE Canton, Ohio

Associate of Applied Science Degree in Mechanical Engineering Technology

CERTIFICATES

Current clearance from The Department of Defense

Q clearance from The Department of Energy

Certified Technologist through NICET

Six Sigma Green Belt certificate

AWARDS

NASA Design Award for new product design

Program Performance Award for F-35 program support

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