PROVIDING LEADERSHIP IN QUALITY MANAGEMENT SYSTEMS
JEFFREY P. TUTHILL
Lacey, WA 98513 (408) 545-8155
Quality Engineer
*Q.S. Management, QA & ISO Awareness Training, provide cGMP development
*MRB & CAB - ID N-C Trends, ECO & CMB Review
*Working Knowledge * ISO 9001, ISO 13485, ISO 14971 & FDA QSR
*Develop & Revise QSM Documentation
*Site/Process/Product Inspections and QS internal auditing
*CAPA & SCAR Planning & FTA/FMEA for Failure Analysis
HIGHLIGHTS
* Supported QMS disciplines, ISO & GMP training and performed
internal/supplier auditing at Abbott Hematology, Pacific Scientific, NNDT, and
Proteus Industries
* Extensive experience with MRB & CAB & cross-functional teams, including CO
and CMB Review with industry leaders like Abbott, Pacific Scientific, NNDT and
Proteus Industries
* Developed & implemented FDA & ISO QSM policies, plans & procedures with
Abbott Hematology, Pacific Scientific, NNDT, American Computer Service & Proteus
Industries
* Adept at developing and revising (streamlining) documentation to improve
processes as a Sr. Engineer, Mgmt. Representative & Field Service Office Manager
* Very experienced at internal auditing and product/process inspections, most
recently conducted a focused audit of the Reference Lab at Abbott.
* Implemented closed-loop CAPA & SCAR Planning for closure and FTA/FMEA for
Fault Analysis & Cut 50% of repair costs with trend analysis at American Computer
Service in Okinawa, Japan, and produced Metric Definitions at Abbott
EMPLOYMENT HISTORY
Abbott Hematology (Abbott Diagnostics Division), Santa Clara, CA (Laid-off thru
downsizing) 8/2007 * 8/2008
Quality Systems Engineer
* Revised site procedures in accordance with Division and Regulatory
requirements and led site in documenting and reporting Quality System Initiative
(QSI) Monitoring activities. Process owner of Metric Definition Forms for trend
analysis and metric presentations to Management.
* Conducted unscheduled and focused internal audits, effective checks, and
assisted in developing CAPA Plans. Made reports to Management Review meetings and
attended MRB meetings. Worked with 21 CFR Part 820, ISO 13485 and ISO 14971, and
Master Validation Plans for Blood Analyzers.
CDI Professional Services, Oxnard, CA (Contract ended) 8/2006 * 7/2007
Senior Quality Assurance Engineer (Contracted to Pacific Scientific in
Hollister, CA * Managed QA Technicians and Inspectors)
* Develop Unit Log Books and provide Quality Inspections of manufacture and
testing for Fiber Optic Cable Assemblies (FOCA), and Flight Termination Assembly
(FTA) in the THAAD Missile Program and provide QA Checks and stamp-offs on Test
and Inspection processes.
* Provide Internal Audits as part of ISO 9001/AS 9100 Quality Management
System maintenance and participated in CAB & MRB meetings.
Novo Nordisk Delivery Technology, Hayward, CA (Division Dissolved) 3/2005 -
5/2006
Senior Quality Systems Engineer * Managed Quality Engineers
* Developed Work Instructions and SOPs for QSR disciplines and for ISO 9001,
ISO 13485 and MDD compliance
* Documented ISO 9001/13485 Quality Manual, maintained CAPA system for Device
Development and Production, developed quality manual for Failure Analysis
Laboratory and promoted philosophy for continuous improvement. Participated in
MRB meetings. Participated in New Product Release of AERx iDMS for clinical
trials.
American Computer Service - Chatan, Okinawa, Japan (Contract Ended) 2/2002 -
10/2004
Field Service Office Manager * Managed 3 Field Service Offices (6
Technicians)
* Implemented statistical analysis of warranty expiration for a 50% savings of
repair costs. Addressed Customer Complaints and scheduled Repairs.
* Conducted Annual Internal audits of the three offices generating an audit
report and corrective action plan for Management and FSO employees
Proteus Industries Inc., Mountain View, CA (Laid-off resulting from 9-11)
6/1997-11/2001
Management Representative * Managed Quality Engineers and Technicians
* Led company in pursuit of QS-9000 registration, established Vendor Audit
Program, SCAR process and MRB committee meetings.
* Participated in Management Review Team to analyze and establish cost
reduction efforts, continuous improvement short and long term quality planning.
Created Improvement measures that improved nonconformity resolutions by 72%
within 1st year of use
* Implemented Advanced Product Quality Planning (APQP), participated in
Mistake Proofing, FMEA, R&M and MTBF statistics
TUV Essen- San Jose, CA (Relocated to CA) 1996 * 1997
Senior Compliance Engineer * Managed 2 Product Test Technicians and Product
Safety Laboratory
* Tested and certified client company products for CE and GS markings
* Generated Product Reports and Technical Files for compliance with various
International Safety Standards like IEC 60950, IEC 61010, IEC 60601-1 among
others. Worked with LVD, MDD, IVDD and Telecom Directive
JEFFREY P. TUTHILL Page 2
EMPLOYMENT HISTORY (continued)
EC Technical Compliance, Nashua, NH and associated with L-CAD, Salem, NH 1992 -
1995
Technical Consultant (Sole Proprietorship)
* Trained and assisted client companies in documenting and auditing quality
system functions
* Led over six (6) companies to successful completion of ISO 9000
Registration
* Created and Administered Case Study Workshop that generated client companies
for ISO 9000 consulting services
National Standards Authority of Ireland (NSAI) (Contract Ended) 1989 * 1992
North American Certification Services, Merrimack, NH
Managing Technical Consultant, U.S. Operations
* First U.S. representative for the National Standards Authority of Ireland, a
European Notified Body to many EU New Approach Directives
* Managed the U.S. Operations, generating sales for NSAI services to companies
shipping into the EU Single Market
* Administered Workshops in the U.S. for EU Single Market compliance and ISO
9001 QMS
* Participated in Quality System audits to ISO 9001 and ISO/IEC Guide 25
* Received ISO 9000 Lead Auditor Training from BSI while in the employ of
NSAI
PRIOR EXPERIENCE
Prior experience includes Principal Engineer for Product Safety at Prime
Computer, Framingham, Massachusetts; Product Safety Engineer at Wang
Laboratories, Lowell, Massachusetts; Laboratory Test Technician and Associate
Engineer at Underwriters Laboratories, Melville, New York; Electrical Assembly
Technician at Grumman Aerospace Corporation, Bethpage, New York.
PROFESSIONAL CREDENTIALS
* TECHNICAL ADVISOR ON USNC: U.S. Technical Advisor to IEC (International
Electrotechnical Commission) serving on the USNC for IEC TC 62 (for IEC 60601-1
[M E Equip.], TC 74 (for IEC 60950 [I T Equip.]) and TC 66 (for IEC 61010 [A
T/Lab, Process Equip]). Also familiar with IEC 60664 (Insulation coordination for
equipment within low-voltage systems), EIA/JEDEC and UL Standards for printed
circuit boards. Very familiar with ISO 9001, ISO 14001, ISO 13485 and 21 CFR Part
820. ASQ Associate Membership 2008/2009.
* PARTICIPATION: Participated in NCSLI (National Conference of Standards
Laboratories) regional meetings, IEEE PSES (Product Safety Engineering Society)
and currently an Associate membership in ASQ. I 'm also familiar with ISO 17025
Lab assessments, NRTL process of OSHA and Laboratory Accreditation through A2LA.
* SELF EMPLOYED CONSULTANT: Successfully consulted ISO 9000 Quality Management
Systems with the following companies: Ametec Inc., Barksdale Controls (Division
of IMO), Beckman Instruments, Exide Electronics, G.W Lisk Co., Keithley Metrabyte
and Krebs Engineers. Consulted ISO 9001 improvements at Proteus Industries Inc.
* TRAINING & INSTRUCTOR QUALIFICATIONS: Received BSI Lead Assessor training
and NSAI ISO 9000 Workshop training. Administered six general ISO 9000 Workshops
in the US and five company in-house workshops for NSAI. Guest Instructor of ISO
9000 course for graduate studies class at Middlesex Community College in Lowell,
MA. Developed ISO 13485 Workshop for awareness training.
* PUBLISHED AUTHOR: Articles on Quality Management in Software and Service
Industries published in the ISO 9000 Handbook, formally a CEEM Publication.
Novel: Gift of a Blue Ball * Path of a Yuta in Okinawa - iUniverse.com.
COMPUTER SKILLS
Microsoft Windows, Office, Word, Excel, PowerPoint, Outlook, and the Internet
EDUCATION
* AAS Degree in Environmental Engineering - State University of New York *
Farmingdale, New York
* Wang Labs: * Technical Writing, Program Management, Time Management &
Coping With Stress.
* Prime Computer: Public Speaking and Presentation.
* National Standards Authority of Ireland (NSAI): Quality Management Workshop
and received training to administer Workshops in US.
* British Standards Institute (BSI): ISO 9000 Lead Assessor Training
* AAMI: FDA Quality System Regulation Part 820 * Requirements and Industry
Practice Course
* ASQ: Design Control Requirements
* British Standards Institute (BSI): Webinar - How to Prepare Design Dossiers
and Technical Files for Vascular Products
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