Quality Control Engineer

John De Herrera

Technical Writer

Documentation & Validation

Army National Guard, (SP 4)

*** *. ****** ***

714-***-**** Home:

714-***-**** Cell:

Office Clerk with Special Clearance

(Special Clearance expired)

Fullerton CA 92833

*******@*****.***

Completed 8 yrs in ARNG

Summary of Skills

Wide range of technical skills and problem solving for engineering, quality

and mfg. departments at regulated industries:

. Technical Writing, Editing, Illustrating, using Microsoft Word, Adobe

PageMaker, FrameMaker, Arbortex Epic Publishing, Adobe InDesign,

Adobe Illustrator, RoboHelp/RoboSource, Adobe Flash & CorelDraw.

. Documentation & Validation Associate: FDA/cGMP/ISO/EMS/HIPAA/Dental

Lab/AS/QS

. Hardware & Software Qualification for: IQ, OQ, PQ, P2Q, FAT, UAT/SAT

. ISO13485, 14001 CEQA/NEPA & ISO 50001 Management System Standards

documentation.

. Food, Drugs & Cosmetics: Documentation of policies, procedures,

processes, protocols & work instructions.

. ASM/ASTM testing, GPS & IT: Hardware & Software documents.

1995 - Present

Compliance Documents and Validation Associate

Contract Agencies

I work as a contractor involved in documenting and validation testing for

FDA and ISO compliance. Most recent: Shoprider, where I created a User

Manual for their new Power Wheelchair. Endologix where I was hired as a

Validation Engineer and conducted equipment qualifications per ISO13485.

Previous experience with J&J/Cordis/Webster creating and executing

validation protocols. Also, Altura Pharmaceuticals, documentation and

validation of solid and liquid packaging machines. Worked for M&O Perry on

Automated Liquid Fillers for vials, Worked for Magellan GPS, designing and

creating new Instruction Manuals. Worked for Shur-Lock Aerospace creating

SOPs for New F35 Aircraft. Worked for Integrated Medical Systems (military

medical equipment), Delta Dental IT, and Newport Medical, documenting a new

Lung Ventilator with SOPs and 510K submissions. Worked for SaintGobain

Fluid Systems R&D Lab developing modern test methods for ISO compliance.

Worked for AlleCure, biopharmaceutical developing SOPs for cGMP compliance.

Returned to Beckman Diagnostics Division and worked for 11 months in the

Test Engineering department, creating SOPs for FDA compliance.

1979 - 1995

Writer/Editor/Desktop Publisher

Beckman Corporate

Technical writing, multi-language editing, desktop publishing Instruction

Manuals, Service Manuals, Instruction Sheets and other writing assignments.

Documentation projects for FDA, ISO, UL, CSA MPRII, and other standards for

products.

1973 - 1979

Materials and Process Lab

Beckman Instruments R&D Labs

Set up and operated a Materials and Process Lab for Beckman Microcircuits

Division. After three years, switched to Process Division and ran three

Application Labs for Industrial, Science and Automotive process instruments

development.

1970 - 1973

Test Engineer

Robertshaw Controls, Special Projects Group (R&D Lab)

Responsible for electronic, mechanical, and chemical tests and written

reports on these tests. Projects included development and testing of

electronic ignition systems, computer controlled environmental systems and

other projects.

1968 - 1970

Metallurgist

LaFiell Aerospace Manufacturing

In charge of Metallurgy Lab. Duties included: chemical tests, DT and NDT

tests, metallography, heat-treating, and mechanical inspection of aircraft

parts on J2 Rocket and Lunar Excursion Module parts for the Apollo Program.

Education

High School graduate

(College prep courses with emphasis on English Literature.)

AA Metallurgy, Fullerton College

Took additional courses in metallurgy and electronics and earned

certificates.

Technical Training

Electronics

Technical college courses and Company Training courses.

Metallurgy Lab. Courses

In addition to duties in the metallurgy lab and quality control of

production, continued taking technical college courses and Company Training

courses for certification:

Certificates:

Metallurgy Mechanical Inspection Magna-Flux Tensile

Certificate Inspection Testing

Heat Treating Composite Materials Dye-Penetrant Microscopic

Construction Inspection Analysis

Metal Epoxy-Bonding: Metal & Boroscope

Roto-Forming Composite Inspection

Computer Courses ( IBM Type)

Windows 2010/NT/XP Microsoft Word 2010, QuarkXPress 7

XP

Framemaker SGML, Microsoft Access CorelDRAW 8

XML 2010

Arbortex Epic Microsoft Excel Digital

Publishing 2010 Photography

Adobe Acrobat 4.0 Microsoft PowerPoint RoboHelp/RoboSou

2010 rce 7

Adobe Illustrator 4 Adobe Creative Suite HTML/SGML/XML

Adobe InDesign SnagIt screen Microsoft Visio

capture

Company Training:

Project Risk Quality Control of Technical

Management Management Production Writing

Regulation Desktop Composites & Time

Compliance Publishing Adhesives Management

Problem Solving

Strong motivation to learn new skills, read science and technical

literature, solved some major engineering problems, make friends easily,

good verbal and writing skills. Have written approximately fifty articles

for science and technology web suite, Frontiers of Science, Beckman Life,

Technical Writing Style Manual for Beckman Scientists and Engineers and

interviewed Dr. Beckman for his biography.

Volunteer

Youth Science Centers

Served as Vice President and Board member of Youth Science Centers of

Fullerton, Hacienda Heights, and Pico Rivera. Built Tesla Coil, Van de

Graph Generator, Spectrum Tubes, Brain Wave Monitor, and other items useful

in teaching science.

Hobbies

Photography, Electronics, Air Brush Art, Flower Gardening and studying

philosophies of science and religions.

Memberships

Member of Monorail Society, LENR Energy Reactors Group, former American

Society of Metallurgy and Toastmasters.

Salary History

$27 - $45 per hour as a Consultant/Contract employee

Please call so we can discuss your requirements for technical

documents.

Contact this candidate