Dr. Andrew J. Perry, P.E.

NSPE, IECQ-ECCC, RABQSA, ASQ-CQA

Serving: Worldwide

N. Calif. Office: 1081 Wright Avenue Mountain View, CA 94043

S. Calif. Office: 270 Caldera Street Perris, CA 92570-5528

Phone: 951-***-**** Cell: 650-***-**** Fax: 954-***-****

Email: abp8g3@r.postjobfree.com

Web: http://www.NewWorldConsultingService.com

Consultant / Sr. Quality Professional / Instructor

Lead Auditor / Project Manager (Power) / Technical Expert

A. OBJECTIVES

1. Consultant. utilizing Process Mapping to identify, capture and

a. Training and consulting with senior management implement best practices that enhance compliance

and functional groups to impart understanding of with the standards and regulations referenced in Ob-

the following new Standards and Regulations, and jective 1a.

how compliance can be achieved by a leading in-

ternational provider of medical, electronics, semi-

conductor, wireless, telecommunications, aero- 2. Directing 510k (Pre-market Notification) and PMA

space, optics, computer products, or power genera- (Pre-market Approval) activities (Temp.)

tion, with minimal effort and schedule impact to the Assuring compliance with requirements for submitting

following standards and regulations: 510k and PMA applications for medical devices to the

AS 9100/ ISO 9001/ 16949/ 13485/ 14001 / FDA, including:

14971 International Quality Management Sys- When these submissions are required

tems (QMS) Information required in each submission

FDA QSR-cGMP (U.S.), CMDCAS (Canada),

FDA review process involved.

MDD (Europe) and PAL (Japan) Medical Device

Regulations 3. Engineering/Technical Program/Project Manager -

Int l. Standard for assessing electronic compo- Energy/Power (Temp.)

nents and production processes according to Program Management and contract execution for En-

1

HSF requirements, QC 080000 2IECQ 3HSPM ergy/Power Generation. Interface with subcontrac-

for 4WEEE and 5RoHS tors, customers, government agencies, and plant site

b. Development and implementation of a QMS using

functions. Technical program and management focus

Process Mapping with the above standards to

for engineering issues. Design and development sup-

identify, capture and implement best practices .

port. Resolution of critical technical issues. Verifying

c. Acting as Director of Quality / QMS Management

proper application / use of parts. Management of

Representative, including establishing and directing

suppliers and internal support staff. Negotiating and

Supplier Control, Internal Quality Audit, Correc-

managing change orders. Providing balanced deci-

tive / Preventive Action (CAPA), Document Con-

sions between technical requirements, schedule, cost,

trol, Validation / Revalidation, ISO 14971 Risk

and quality.

Management, coordination with customers, and in-

terfacing with Notified Bodies (Registrars); acting

4. QMS / Technical Expert and Expert Witness

as champion for Quality and Customer Satisfaction

for the Plaintiff or Defendant, with expertise in the

in a leading international provider of products

(1) standards, regulations and activities referenced in

compliant with the standards and regulations refer-

Objective 1a, (2) Engineering/ Technical Program/

enced in Objective 1a.

Project Management activities, and (3) investigative

3. ISO 9001/13485 / AS 9100C Lead Auditor (Temp.) process, case review procedures, report preparation

Planning, preparing and leading QMS audits for an in- containing expert opinion; providing depositions and

ternational Certified Body (Registrar), or managing a court testimony.

company Internal Audit programs in the above fields,

B. SUMMARY

Experience in variety of product lines includes (1) developing relationships with key customers, (2) determining cus-

tomer expectations and assuring implementation company-wide (3) setup and direction of Customer, Quality, Reliabil-

ity, Design, Manufacturing, Crisis Management, Continuous Improvement activities, (4) setup of global customer feed-

back systems working in an international environment, including the European and Asian Market, (5) establishing cor-

porate strategic plans and objectives to exceed customer requirements, (6) oversight of Risk Management activities per

ISO 14971.

1

Substance Free. 2 International Electrotechnical Commission Quality Assessment System for Electronic Components.

Hazardous

3 4 5

Hazardous Substances Process Management. Waste of Electrical and Electronic Equipment. Reduction of Hazardous Materials.

Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

C. INTERNATIONAL STANDARDS EXPERIENCE

09/2006 - Present

THE ELECTRONICS COMPONENTS CERTIFICATION CORPORATION (ECCC)

U.S. National Authorized Institute for the International Electrotechnical

Commission Quality Assessment System (IECQ) for Electronic Components

1. ECCC Technical Review

Review and approval of Certification Body (Registrar) applications for certifications of companies assessed to Interna-

tional Standard QC 080000 IECQ-HSPM, Hazardous Substances Process Management (now over 1,000 world-wide).

2. ECCC Board Member

Participation in planning and oversight of the execution of the goals and activities of the former ECCB.

Participation and oversight of the finalization of the IECQ HSPM and ECMP pilot projects.

Participation in providing input to the IECQ.

3. NSSA, SSA, and Rules of Procedure Review Committee

Participation in the review, revision and reissuance of the original:

ECCB Rules and Regulations

IECQ-ECCB NSSA and SSA U.S. and International Standards and documents;

also see Section L. PUBLICATIONS

D1. CONSULTING EXPERIENCE

10/1977 - Present

New World Consulting Service, N. Calif. (Mountain View Office) and S. Calif. (Perris Office)

Principal/Sole Proprietor (position/title at client companies italicized).

1. Trimedyne, Inc., Lake Forest, CA (12/2010-Present) Action: Created Quality Manual, procedures and

forms. Conducted ISO 9001 / ISO 17025 Lead Inter-

Product: Surgical lasers, Holmium products, surgical nal Auditor training

fibers, handpieces and laser accessories Results: Registration obtained.

Position: ISO 13485/FDA/CMDR/MDD Consultant

Action: On-going internal audit of the quality man- 4. Digi-Com Electronics, Richmond, CA (09/2009-Present)

agement system and two technical files 5. Quality Circuit Assemblies, San Jose, CA (11/2009-Present)

6. EMED Technologies, El Dorado Hills, CA (12/2009-Present)

2. Integrated Composites Inc. (ICI), Marina, CA

(07/2011-Present) Position: ISO 13485:2003/ FDA Consultant

Product: Printed circuit assemblies and equipment for

Position: AS9100-C Consultant all industries.

Product: Design, development, and manufacturing Problem: ISO 13485: 2003 initial certification within 6

company specializing in high-performance structures months, lacking complete QMS Internal Audit.

and assemblies for aerospace, defense, and industrial Action: Revised Quality Manual, created procedures

applications. and forms as needed, and conducted complete QMS In-

Problem: Lacking complete QMS Internal Audit to the ternal Audit.

AS9100 Rev. C with major customer and registrar au- Results: Completed on time; registration obtained.

dits imminent.

Action: Conducting complete QMS Internal Audit and

7. Vital Wear, S. San Francisco, CA (07/2008-03/2009)

identification of corrective action requirements.

Results: Obtained AS9100 Rev. C registration. On-

Position: ISO 13485:2003/ FDA/ CMDR/ MDD/ Con-

going internal audits conducted.

sultant

Product: Thermal/compression systems for use in

3. Evans Analytical Labs, RTP Div., Santa Clara CA

managing chronic pain and accelerating the recovery

(01/2011-Present)

from injury.

Problem: Transition from ISO 9001 to 13485 with CE

Position: ISO 9001 / ISO 17025 Consultant

mark to meet marketing goals to commence European

Product: Design, development, and reliability testing

and Canadian sales within 8 months.

services for product qualification.

Action: Created detailed milestone chart of entire pro-

Problem: ISO 9001 / 17025 initial certification within

gram, reviewed entire QMS system, revised and added

9 months, lacking QMS documents and implementa-

Quality Manual, procedures and forms as needed.

tion.

Results: Completed on time.

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Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

8. Focus Diagnostics, Inc., Cypress, CA (11/2007-05/2008) As a result, the Company also asked me to audit

Focus Laboratory Svs., Cypress, CA (11/2007-05/2008) Juarez, after which this site implemented my findings

and passed their BSI Assessment. I now have annually-

Position: ISO 13485:2003/ FDA/ CMDR/ MDD Con- renewable contract to plan, conduct and report com-

sultant pany-wide Internal Audits and review proposed correc-

Product: Advanced Healthcare

tive actions.

Reference Laboratory

Diagnostics Products

10. Invitrogen, Camarillo, CA (Merger) (06/2006)

Clinical Trials

Zymed Laboratories, South San Francisco (Merger)

Problem: (Similar to Biosense Webster below) Corpo-

Caltek Laboratories, Burlingame, CA (Merger)

ration certified to ISO 13485:2003. Registrar Assess-

ment scheduled the following week. Extensive organ-

Position: ISO 13485:2003 / FDA cGMP/QSR, MDD

izational changes and key positions vacant causing

doubt as to whether company was still compliant. and CMDCAS Consultant

Action: In 3 days, performed Gap Analysis which (1) Product: Manufacture of RUOs, ASRs and IVDs and

Reviewed documented Quality System and submitted ancillary GPRs), majority of products antibody based

recommendations for changes. (2) Assessed all de- with applications in IHC and Flow Cytometry.

partments and recommended Corrective Actions, (3) Problem: Invitrogen certified to ISO 13485. (1) Re-

Conducted Closing Meetings for each of the above fa- cently acquired Caltek and Zymed and is undergoing

cilities to provide ISO 13485 QMS training to Senior

relocation to S. Cal. (Camarillo); Registration/Upgrade

Management to identify major nonconformances de-

Assessment to cover all locations which with extensive

tected that day, and recommend effective corrective ac-

organizational changes. Various key positions are still

tion, (4) Conducted ISO 13485 Orientation Classes

vacant. (2) Various system problems detected by FDA

with all management and professional personnel.

on last inspection unresolved. (3) Currently no Internal

Results: Passed TUV Assessment and recertification,

qualified Auditors or QA personnel capable of detect-

and received an annually-renewable contract to plan,

conduct and report company-wide Internal Audits and ing underlying problems and recommending fixes.

review proposed corrective actions. Action: Completed audit of complete QMS and closed

out audit CAPAs and previous FDA findings a week

9. Biosense Webster, Inc. (Johnson & Johnson), Irwindale ahead of schedule o assure successful relocation with

(LA Area), CA and Juarez, Mexico (02/2006-12/2007) minimal cost and schedule impact.

Results: Company passed ISO 13485 Registrar As-

Position: ISO 13485:2003/ FDA/ CMDR/ MDD/ Pre-

sessment and satisfied FDA findings in time. Received

BSI Consultant

verbal commendation and opportunity for an ongoing

Product:

business relationship.

Advanced diagnostic and therapeutic electro-physio-

logical catheters

11. Intuitive Surgical, Inc., Sunnyvale, CA (09/2005-03/2006)

3-dimensional, real-time cardiac color-coded map-

ping, navigation and ablation systems.

Problem: Corporation certified to ISO 13485:2003. Position: ISO 13485/ FDA cGMP/QSR, MDD and

Registrar Assessment scheduled following month. Ex-

CMDCAS Consultant

tensive organizational changes and key positions va-

Product: State-of-the-art "Intuitive" Motion Enhanced

cant resulting in Internal Audits not being conducted.

Action: In 2 weeks, (1) Reviewed documented Quality 3-D Vision Laparoscopic Surgical Robotic Surgical

System and submitted recommendations for changes. Systems

(2) Planned and conducted complete ISO 13485/ Problem and Action: Same above except that it was

CMDCAS/ FDA QMS Assessment of all departments

the VP of Quality who left.

and Executive Management, and recommended Correc-

Results: Company passed the ISO audits and FDA in-

tive Actions, (3) Conducted daily wrap-up meetings to:

a) provide ISO 13485/ CMDCAS QMS training to spection.

Senior Management to identify major nonconfor-

mances detected that day, and recommend effective

12. SurgRx, Inc., Palo Alto, CA (07/2005-08/2005)

corrective action.

Results: Irwindale site failed BSI Assessment and was

going to lose ISO certification, with losses of millions Position: ISO 13485 / FDA cGMP/QSR, MDD and

of dollars in international sales. The BSI Lead Assessor CMDCAS Consultant

knew of me and knew I had just finished my audit.

Product: State-of-the-art Electronic/ Electro-

mechanical Rapid Vessel Sealing and Transection He-

Upon receiving my report, BSI advised the Company

mostasis Systems.

that if they implemented all my recommendations they

could retain their ISO certificate.

Page 3 of 10

Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

with internal auditors observing. (3) Conducted daily

Problem: Start-up, pre-IPO Corporation desiring certi-

wrap-up meetings to: a) provide ISO 13485/ CMDCAS

fication to ISO 13485:2003 and a system compliant

QMS training to Senior Management and internal audi-

with FDA cGMP/QSR, MDD and CMDCAS. ISO Reg-

tors, b) identify major nonconformances detected that

istrar Assessment and FDA Inspection scheduled next

day, and recommend effective corrective action. (4)

month. Quality Management System had not been Trained and certified auditors to ISO 13485:2003 and

fully documented. ISO 19001:2000.

Action: In 2 weeks, (1) Reviewed documented Quality Results: Company revised QMS documentation and

System and submitted recommendations for changes. effectively implemented in time to pass ISO 13485/

CMDCAS Registrar Certification Assessment. I re-

(2) Created a detailed 20-page Risk Management Sys-

ceived referral for subsequent consulting assignment

tem Audit Checklist, (3) Created an Audio-Visual

from QA Director.

PowerPoint Presentation on CD of the requirements for

implementing ISO 13485:2003 which was distributed

15. Applied Materials/AKT (SQA), Santa Clara, CA

world-wide. (03-2000-02/2001)

Results: Received a referral to the above company af-

ter assignment completed. Position: ISO 9001 Program Director

Product: Capital equipment for the manufacture of Flat

Panel Display silicon material

13. Welsh-Allyn, Inc., San Diego, CA 041/2004)

Problem: Corporate requirement for all 15 business

units world-wide (who commenced 3 months previ-

Position: ISO 13485 / FDA cGMP/QSR, MDD and

ously with full staff) to implement ISO 9001 and be

CMDCAS Consultant registered in 14 months.

Product: Electronic/Electromechanical Coronary Di- Action: With only one assigned assistant, developed

agnostic Equipment aggressive, comprehensive catch-up plan, estab-

lished and implemented ISO 9001ahead of schedule.

Problem: Numerous deficiencies noted in the functions

Results: Received ISO 9001 Certification ahead of 5

noted below by the Registrar and FDA.

other business units. Received Plaque and Letter of

Action: In 1 week, reviewed Complaint Investigation,

Commendation from President and Executive Staff

Handling, Reporting and Document Control Systems

sent world-wide, mentioning above problem and solu-

and in one week submitted a detailed action plan for all tion.

departments.

16. Lucas Novasensor, Fremont, CA (11/1997-03/1998)

14. Int'l. Remote Med. Imaging Sys., Chatsworth, CA

(09/2004-10/2004) Position: Director, Quality & Reliab. Assur. Director

Product: Fluidic/Optic Sensors, Silicon Microstructures.

Position: ISO 13485 / FDA cGMP/QSR and CMDCAS Problem: (1) Previous QA&R Director left suddenly to

Consultant assume position as BART Reliability Directory. (2) TS

Product: Remote medical imaging systems 16949 (Auto), ISO 13485 (Medical), and AS 9100

Problem: Company certified to ISO 9001:1994. ISO (Space) Quality Management Systems all needed to be

13485/CMDCAS Registrar Certification Assessment upgraded and recertified. Department needed reorganiza-

scheduled following month. Internal Audit conducted tion and morale boost. Statistical Q.E. about to be termi-

month previous with no findings detected. New QA nated for productivity and organizational issues.

Director convinced (1) numerous undetected system Action: Performed fixes for the above issues in 3 months.

problems existed, and (2) internal auditors not capable Results: Received 3rd party Certification to all Quality

of finding problems. (3) Senior management gave QA Systems. Statistical Q.E. voted Employee of the Month .

Director 2 weeks to a) train auditors, b) find all signifi-

cant problems, and 3) implement adequate corrective 17. KAMET Precision Machining, Santa Clara, CA

(09/1996-09/1998)

action.

Position: Director, Quality & Reliability Assurance

Action: In 2 weeks, (1) Reviewed documented Quality Product: R&D/Prototype Precision Machining

System (Level 1 and 2 documents) and submitted rec- Problem: Start-up company needed a ISO 9001 Quality

ommendations for changes. (2) As internal auditors Management System to be prepared, implemented and

certified.

were in name only and totally unqualified, planned and

Action: Set up and implemented Quality System.

conducted complete ISO 13485/CMDCAS QMS Pre-

Assessment and recommended Corrective Actions,

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Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

18. Huntington Mechanical Labs, Mountain View, CA Action: Set up and implemented Quality Systems.

(06/1995-07/1996) Results: Successful organization was incorporated into

the corporation location. Received Letters of Commenda-

Position: Director, Quality Assurance tion from the President, VP and Director of Eng.

Product: Aerospace Vacuum Products and Prototype

Mechanical Assemblies. 22. OmniTel, Inc., Fremont, CA (06/1988-06/1989)

Problem: ISO 9001 (Industrial) and AS 9100 (Space)

Quality Management Systems needed to be prepared, im- Position: Director, Quality & Reliability

plemented and certified. Product: Modems

Action: Set up and implemented Quality Systems and Problem: Start-up company needed a ISO 9001 Quality

conducted various training courses. Management System to be prepared, implemented and

Results: Successful organization relocated to larger facili- certified.

ties. Action: Set up and implemented Quality Systems.

Results: Organization was successful until I left.

19. Shin-Etsu Polymer Corp., Fremont, CA (01/1993-04/1993)

23. J. R. Technology, San Jose, CA 01/1987-06/1988

Position: Director, Quality & Reliability Assurance Position: Quality Assurance Director

Product: Medical and Automotive Instrument Panels. Product: R&D/Prototype Precision Machining

Problem: (1) Previous QA&R Director left without re- Problem: set up of IS0 9001 Aerospace Quality Man-

placement. (2) TS 16949 (Auto) and ISO 13485 (Medi- agement System needed to be prepared, implemented and

cal) Quality Management Systems needed to be prepared, certified.

implemented and certified. Action: Set up and implemented Quality Systems.

Action: Set up and implemented Quality Systems in three

months. 24. TIW Systems, Inc., Sunnyvale, CA (05/1986-12/1989)

Results: Successful organization relocated to Japan.

Position: Director, Quality & Reliability

20. Pulnix America Corp., Sunnyvale, CA (05/1992-02/1995) Product: Aerospace Satellite Antenna Systems and Tele-

communications Equipment

Position: Director, TQM/ISO Program Problem: MIL-STD-9858C Aerospace Quality Manage-

Aerospace/ Medical Security, Video, Photoelectric In- ment System needed to be prepared, implemented and

struments/ Controls. DCAS-approved.

Problem: (1) Previous Director left without replacement. Action: Set up and implemented Quality Systems.

(2) ISO 9001 (Industrial), ISO 13485 (Medical) and AS Results: Successful organization relocated to larger facili-

9100 (Space) Quality Management Systems needed to be ties.

prepared, implemented and certified.

Action: Set up and implemented Quality Systems and 25. Honeywell Aerospace, Instruments Division

conducted various TQM training courses. Minneapolis, MN (11/66-09/67)

Results: Successful organization relocated to larger facili-

ties. Position: Sr. Q.A. Project Engineer

Product: Spacecraft Indicators and Meters

21. National Nuclear Corp., Sunnyvale, CA (09/1989-02/1992) Problem: Delays in production and high customer return

rate.

Position: Director, Quality Assurance, Action: Prepared and issued Quality System Plan, chose se-

Product: Aerospace/ Medical/ Security Radiation Moni- lect "Blue Ribbon Committee" to assure effective corrective

toring Equipment action. Acted as Chairman of MRB, Failure Analysis Board,

Problem: (1) Previous Director left without replacement. First Article Engineering Analysis and Design Review

(2) ISO 9001 (Industrial) and ANSI 10CFR50 (Nuclear) Results: Received numerous Letters of Commendations

Quality Management Systems needed to be prepared, im- and references toward my P.E. license.

plemented and certified.

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Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

D2. OTHER CONSULTING EXPERIENCE

(Asterisks [*] indicate where Letters of Commendations were received. Copies will be provided upon request)

1. NASA/Ames Research Center, Mountain View, 3. G.E. Advanced Reactor Systems, Sunnyvale, CA

(05/78-06/1981)

CA (04/1998 06/1999)

Position: Sr. Q.A. Project Engineer

Position: ISO 9001 Advisor and Lead Auditor

Problem: Entire project behind schedule.

Problem: Majority of personnel against ISO, Pre-

Action: Performed detailed planning, using results

Assessment indicated severe systemic problems.

of planning, directed supplier, in-plant and site ac-

Action: Conducted training classes, performed co-

tivities and performed project/customer coordina-

ordination with top management and process own- tion.

ers, and worked with groups to prepare needed Results: My assigned plant systems were the first of

documents. all plant systems to ship to site, arriving ahead of

Results: Created appreciation for the benefits of the schedule.

ISO program, obtained cooperation needed, imple- The local newspaper interviewed me and featured

an article with a photo of myself next to the exten-

mented ISO program ahead of schedule, and ob-

sive system hardware at the plant site.

tained ISO certification without one Major Noncon-

* Received Letter of Commendation from QA Direc-

formance.

tor.

* Received Letter of Commendation from NASA

* Received Letter of Commendation from QA Direc-

Center Director and ISO Program Director.

tor.

2. GE Nuclear Energy Business Operations, 4. General Electric, Television Div., Syracuse, NY

San Jose, CA (05/1985-04/1986) (10/67-11/67)

Position: Technical Program Manager Position: Operations Consultant

Problem: Numerous complex, critical technical is- Problem: Poor field reliability, low customer satis-

faction, high manufacturing costs for large-screen

sues at 12 Nuclear Power Plants.

Color TV consoles.

Action: Coordinated with various company and

Action: Prepared the first process flow chart the fa-

customer engineering organizations

cility had ever developed for production and QA

Results: Resolved all issues with minimal cost and

systems. Analyzed these systems and documented

schedule impacts.

detailed recommendations for improvements.

* Received two Letters of Commendation from Sen- Results: Realized immediate increased production

ior Program Management. yields/quality levels and increased field reliabil-

ity/customer satisfaction at lower manufacturing

costs.

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Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

E. AUDITING AND TRAINING EXPERIENCE

(Asterisks [*] indicate where Letters of Commendations were received. Copies will be provided upon request)

09/2002 - Present British Standards Institute, Reston, VA ISO Lead Assessor and Instructor

1. Leading and participating in teams conducting third- e. Transition/Conversion Methods from ISO 9001:1994 to

party Registrar Certification Assessments to global ISO 9001:2000 Quality Management Systems

standard ISO 9001:2000. f. Transition/Conversion Methods from ISO 9001:1994 /

ISO 13485:1996 / EN 46001 to ISO 13485:2003 Quality

2003-06-03 SMA-Cortec 2003-11-03 Alcoa CSI-Ensnda Management Systems

2003-06-23 Gallo 2003-11-05 Robt Bosch-Ont-CA

2003-08-26 Sharp TJ*

2003-11-17 Tanner 2002-08-30 SGI 2003-07-16 Morgan Hill

2003-10-21 Tanner

2003-11-25 Annacis Auto Ter- 2002-9-30 Morgan Hill 2003-08-02 PR-Synovis Caribe*

2003-10-31 ASIC Adv-Sv

minals-Vancouver, Canada 2002-10-28 UMCQP 2003-10-16 Digene-Gaithersbg

2002-11-18 Dallas 2003-10-28 N. Dig-Toronto

2. Conducting public seminars and training courses at

2003-04-23 San Diego 2003-11-11 IntraLase-Irvine

company sites for:

a. RAB-Certified ISO 9001:2000 Lead Auditor per * Received numerous commendations from client personnel,

ISO 19011 guidelines and from the BSI President and Vice President for

b. RAB-Certified ISO 13485:2002 Lead Auditor per

(1) Conducting an ISO 9001/2000 course in Spanish at

ISO 19011 guidelines

Synovis Caribe, Puerto Rico

c. ISO 14971 Risk Management, FDA cGMP-QSRs

(2) Leading an ISO 9001:2000 Certification Assessment in

Regulations, Canadian CMDCAS Regulations.

Spanish at Sharp Electronica Mexico.

d. Understanding and Management Concepts for ISO

9001 and ISO 13485 Quality Management

04/2009 - Present ABS Quality Evaluation Registrar, Houston, TX ISO Lead Assessor

Conducting third-party Registrar Certification Assessments to ISO 9001:2000.

2009-04-07 Bara Infoware 2009-09-02 Streamline Tech 2009-11-10 KIE-CON

2009-07-28 TechRef 2009-10-20 TTI-Tech

02/2006 Present Marion Weinreb & Associates Associate and Supervising Assessor

05/2010 - 05/2011 Ethicon, Johnson & Johnson, Somerset, NJ Lead Contract Supplier Auditor

05/2011 - Present Medpoint, LLC, Greenville, SC Lead Contract Supplier Auditor

Conducting audits of suppliers certified to ISO 9001 / 13485 and FDA-GMP-QSR and review/approval of corrective action plans.

2010-09-06 Minitubes, France 2010-12-07 Pacific Rubber, CA 2011-03-17 Applied Silicon, CA

2010-09-16 Hoosier Springs, IN 2010-12-08 NuSil, CA 2012-05-15 Zefon, Tijuana, Mex.

2010-11-16 Needletech, MA 2010-12-15 Trimedyne 2012-09-10 NSL, Cleveland

2010-11-17 Lacey, CT 2011-03-15 FzioMed, CA 2012-11-28 Trimedyne

2010-12-02 Steven Label, CA 2011-03-23 Dako-Acerna

F1. PERMANENT DIRECT MANAGEMENT EXPERIENCE

1. Memorex Communications Group, Cupertino, CA and supervised construction of test facility to perform

(10/1981-04/1985) special tests. Qualified "worst case" configurations ahead

of schedule and within budget.

Quality Engineering Mgr. & Member Tech. Staff

* Received numerous Letters of Commendations and refer-

Supervision of Reliability/Quality Engineers, and QC ences toward my P.E. license.

Inspection/Test personnel and suppliers for domestic

and international coordination computer peripheral 3. Bunker Ramo/Amphenol, Space & Missiles Systems

products(terminals, keyboards, printers). Conducting Division, Chatsworth (LA Area), CA (04/1976 10/1977)

management interdepartmental plant training program

(SPC, Team-Building). QA Laboratory Dept. Head

* Letter of Commendation. Concurrent with the previous position. Direction of the

Tool & Gauge Room, the Electronics Laboratory, and the

2. Bunker Ramo/Amphenol, Nuclear Products Div. Mechanical/ Materials/ Environmental Test Laboratory in

Chatsworth (LA Area), CA (04/1976 10/1977) the performance of R&D tests, production support tests,

and measuring/test equipment repairs/calibration. Coordi-

Project Engineering Mgr. nating with outside facilities for performance of special

tests for complex AEROSPACE Cable/Harness Assem-

Due date passed for qualifying Reactor Assemblies for

blies and Electric Penetration Assemblies for NUCLEAR

7 Nuclear Power Plants. Obtained agreements to con-

REACTORS. Design of remote control test facility adja-

currently qualify all product requirements in 6 months

cent to main plant to perform Loss of Coolant Acci-

with extremely limited budget; chose select "Tiger

dent/Thermal Conformance/Short Circuit Current nuclear

Team" and directed design activities; coordinated with

qualification tests. Heavy customer involvement.

Nuclear Regulatory Commission, Architects, Utilities;

approved and supervised outside test facilities, designed * Received numerous Letters of Commendations.

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Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

F2. TEMPORARY MANAGEMENT EXPERIENCE

While consulting, also served as Director of TQM, QA & Reliability for:

09/96 - 11/97 KAMET Precision Machining, Santa Clara, CA (R&D/Prototype)

11/97 - 03/98 Lucas NovaSensor, Fremont, CA (ASICs, PCBAs, Sensors, Silicon Microstructures)

10/96 - 04/98 G. Hartzell & Son, Concord, CA (Dental Instruments)

06/95 - 07/96 Huntington Mech. Labs, Mountain View, CA (High-Vacuum Assemblies)

05/92 - 02/95 Pulnix America, Sunnyvale, CA (Security, Video, Photoelectric Controls)

01/93 - 04/93 Shin-Etsu Polymer, Fremont, CA (Medical/Automotive Molded Products)

09/89 - 02/92 National Nuclear Corp., Sunnyvale, CA (Radiation Monitoring Equipment)

06/88 - 06/89 OmniTel, Incorporated, Fremont, CA (Modems)

01/87 - 06/88 J. R. Technology, San Jose, CA (Hi-Tech Machine Shop)

05/86 - 12/89 TIW Systems, Inc., Sunnyvale, CA (Satellite/Telecommunications Antennas)

G. LITIGATION SUPPORT EXPERIENCE

(Copies of Legal CV and authorization letters for these litigations will be provided upon request)

03/1994 - Present

Expert Witness and Technical Expert

San Francisco Bar Association, Association for Defense Counsel; Expert.com

1. Expert Engagement:

Type of Matter: Indiana Superior Court, Liability

Law Firm: William C. Wagner, Esq., Sommer Barnard Attorneys, PC

Case Name: Ecesis, LLC et.al. vs. Inok Investments, LLC, et. al.

Services Provided: Wrote Expert Report detailing inconsistencies with Quality Management System require-

ments as specified in ISO 13485 for Medical Devices and AS 9100 for Aerospace Products.

Disposition: Settled September 2006 based on above Expert Report.

2. Expert Engagement:

Type of Matter: California Superior Court, Class Action

Law Firm: Green Welling, LLP & Kershaw, Cutter & Ratinoff, LLP

Case Name: G. Welling, LLP & Kershaw, Cutter & Ratinoff, LLP vs. Hewlett-Packard

Services Provided: Review of available documents to determine the expected useful life of HP Pavilion

notebook computers to be used as a basis for determining the class range.

Disposition: Settled June 2007 based on above Expert Report.

3. Expert Engagement:

Type of Matter: Missouri Circuit Court, Liability.

Law Firm: LOO Ronnie Penton

Case Name: Adams et.al. vs. DPC Enterprises, LP, et. al.

Services Provided: Reviewing Scene of Accident, Reviewing business processes (Quality

Management Systems) to determine factors contributing to the accident.

Disposition: Settled August 2007 based on Expert Reports.

4. Expert Engagement:

Type of Matter: California State Arbitration, Liability.

Law Firm: Bridgford, Knottnerus & Gleason

Case Name: TMX vs. Allez Spine

Services Provided: Reviewing business processes (Quality Management Systems) to determine culpability.

Disposition: Settled October 2007 based on Expert Reports and Testimony.

Page 8 of 10

Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

H. EDUCATION

(Transcripts provided upon request. Also see Section J)

5. De Anza College, Cupertino, CA

1. Suffield University, Twin Falls, Idaho (GPA 3.7).

City College, Santa Barbara, CA.

Ph.D. Engineering Management, May 2005

Nondestructive Testing, Reliability Engineering, Computer

2. Suffield University, Twin Falls, Idaho (GPA 3.7). Science, Digital & Logic Circuits, State & Federal Law

M.S. Industrial Engineering, May 1981

6. U.S. Army Ordnance School, Officer Training Div. Aber-

3. Suffield University, Twin Falls, Idaho (GPA 3.6). deen, MD.

B.S. Manufacturing Engineering, May 1978 Industrial Engineering, Industrial Management, Production

4. Johns Hopkins University, Baltimore, MD. Management

Toward BSEE 7. School for Technical Experts, Conducted by the California

Board of Registration for Professional Engineers, Long

Beach, CA

I. AFFILIATIONS

(Click on blue hyperlinks for details. *Letters provided upon request)

1. Electronic Components Certification Corp. (ECCC) 5. American Society for Quality (ASQ)

International Electrotechnical Commission (IECQ) a. Senior Member

a. Board Member b. Instructor

b. Technical Review Committee c. Certified Quality Auditor

c. HSPM / QC 080000 / WEEE / RoHS Lead Assessor

6. Who's Who Worldwide

2. California Board of Professional Engineers a. Lifetime Member

a. Registered Professional Quality Engineer (PE);

7. RABQSA Internationall

b. Technical Expert for Examination Development Unit;

a. Certified ISO 9001 and ISO 13485 Lead Assessor

c. Technical Expert for Enforcement Unit

8. British Standards Institute (BSI) *

3. University of Calif., Institute for Social Research* a. ISO 9001 and ISO 13485 Lead Assessor

a. Technical Expert Requirements for Licensed Engineers b. Instructor

4. National Society of Professional Engineers 9. Los Angeles County Bar Association

a. Member a. Technical Expert, Expert Witness

10. San Francisco Bar Register of Experts

5. Quality Digest

a. Consulting & Training a. Technical Expert, Expert Witness

K. ON-SITE COURSE / SEMINAR INSTRUCTOR

J. ASQ BIOMEDICAL COURSES

(Certificates of completion and detailed course descriptions avail- Quality System Courses Duration

able upon request)

1. Executive Overview 1 day

05/2003 Sterilization Methods, Monitoring and Validation.

2. Employee Transition Awareness 1 day

06/2003 Eight Discipline (8d) Problem Solving, Root Cause Analysis,

3. Understanding the Quality System 1 day

Corrective Action and Preventive Action

4. Interpreting the Quality System 1 day

08/2003 Complaint Investigation, Handling, Reporting, Record Keep-

ing, Advisory Notices and Recalls. 5. Quality System Documentation 1 day

09/2003 510k s (Pre-market Notification), PMAs (Pre-market Ap- 6. ISO 9001:2000 to ISO 13485:2003 Conversion 3 days

proval), and FDA Review Process.

7. Implementing the Quality System 2 days

09/2003 Adding Value for an Organization utilizing ISO 9000:2000

and ISO 13485, Including Human Elements.

ISO 9001:2000/ISO 13485:2003 Auditor Courses Duration

10/2003 FDA Quality System Regulation and Audit Process (QSIT).

1. Certified ISO 9001:2000/ ISO 13485:2003

10/2003 Risk Management, FMEA, FTA, HACCP.

Internal Auditor 3 days

01/2004 Design Control for Medical Devices

2. ISO 9001:2000/ ISO 13485:2003 RABQSA

03/2004 Electronic Signatures/Records per 21 CFR Part 11.

Certified Lead Auditor 5 days

04/2004 FDA Pre-Validation and Process Validation.

06/2006 Labeling, Handling, Disposition of Electronic Equipment and

Hazardous Substances U.S., Europe, Japan (1HSF, 2WEEE,

3

RoHS, page 1).

02/2009 Facilitating Project Management Success

Page 9 of 10

Resume of Dr. Andrew J. Perry, P.E. [Rev. 10-08-2012]

L. PUBLICATIONS

Published by Amphenol Bunker Ramo: 1996 The Path to ISO 9001 Registration

1977 Generic Qualification Test Program for Nuclear Power Gen-

2001 NWC ISO 9001:2008 Process vs. Evidence (Look At

erating Station Electric Penetration Assemblies (101 pages)

Look-For) Checklist (with 800 separate questions and an-

swers). Also published as an article on Experts.com

Published by NASA, Ames Research Center, Moffett Field, CA

1998 NASA Reference Publication NRP4-14, A Guide to Im- 2005 NWC ISO 13485:2003 Process vs. Evidence (Look At

plementing ISO 9001, Clause 4.14; Corrective and Preven- Look-For) Checklist (with 1,100 separate questions and

tive Action answers)

Published by International Quality Assessment System for Elec- 2005 NWC ISO 13485-QSR-14971-Mgt. Resp. Audio-Visual

tronic Components (IECQ) with John Fink: Training CD Implementation of ISO and Risk Manage-

2006 Assessment Procedures for Acceptance of Candidate Sub- ment Standards for Medical Devices

ject Matter Experts (SME s) in the IECQ Scheme

Published and sold by New World Consulting Service:

M. AWARDS AND HONORS

2001 University of California, Institute for Social Research, com-

2002 British Standards Institute (BSi) President and Vice President

mendation for leading a panel of experts in determining the stan-

commendation for excellence in conducting an ISO 9001/2000

dard educational requirements applicable to Licensed Profes-

course in Spanish at Synovis Caribe, Puerto Rico and leading an

sional Engineers

ISO 9001:2000 Certification Assessment in Spanish at Sharp

Electronica Mexico. 1998 NASA/Ames Research Center, Mountain View, CA. Commen-

dation from NASA Center Director and ISO Program Director.

2001 Applied Materials/AKT, Santa Clara, CA. Plaque and

world-wide Letter of Commendation from President and

Executive Staff

N. SKILLS

1. Desktop Applications Advanced 25+ yr. 6. Sales Abilities Expert 30+ yr.

Microsoft Office (MSWord, Excel, Power Point), Micro- Customer Coordination, Proposal Writing

soft Project, Microsoft Internet Explorer, Outlook Lotus

7. Development Skills Expert 30+ yr.

Notes, Eudora

Design, Functional, Technical Specs, Requirements Defini-

2. Graphics Applications Advanced 25+ yr. tion, Tech Writing

Various, including Paint Shop Pro

8. Teaching Skills Expert 35+ yr.

3. Analytical Skills Expert 40+ yr. Tech. Training Course Development

QA Internal and Supplier Auditing, TQM, SPC, 6-Sigma, Instructor ISO, QMS, TQM, SPC

Reliability Engineering Instructor Customer Service, Decision Making, Effec-

tive Meetings

4. Management Abilities Advanced 35+ yr.

Corporate Leadership, Direction, Setting, Executive Re- 9. Quality Management Systems Expert 35+ yr.

sponsibilities, Contractor/Supplier Management, Business Concepts, Management, Standards, Plans, Procedures,

Processes Forms, Quality Control (Inspection/ Test)

5. Project Planning Advanced 35+ yr. 10. Language Expert 35+ yr.

Project Leadership, Planning, Scheduling, Control, Spoken/Written Spanish

Resource Management, Project Change Management, Pro-

ject Quality Assurance

KEYWORDS

ISO 13485 Consultant ISO 13485 Auditor ISO 13485 Instructor Lead Auditor Business Processes

AS9100C Consultant AS9100 Auditor AS9100 Instructor Lead Assessor Quality Management System

QMS Instructor QMS Lead Auditor

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