Your Web-Master's Military History & more

My Job History

Qualifications: Experienced in Regulatory Compliance and Quality of in-vitro diagnostic, ultrasound, microwave, radio frequency and cardiac catheter medical devices, prototype through production. Extensive education in Quality Assurance. American Society for Quality (ASQ) Certified Quality Engineer (CQE) and Certified Reliability Engineer (CRE).

Expertise in:

·   Researching, formatting, presenting and revising technical and regulatory information. (28 years)

·   Writing reports, User Instructions, training publications, and thorough, effective procedures compliant to FDA cGMP, QSR, IS09001, EN46001, ISO 13485 and MDD CE Mark. (28 years)

·    Authoring software validation procedures; audit & review of software validation documents. (2 years)

·   Computer systems – CP/M, MS-DOS, Macintosh, Windows 3.1, Win95, Win 2000, Win Vista, WinXP, Win 7 Software,  WordStar, Word Perfect, Microsoft Word, (25 years), Microsoft FrontPage - Web-Master (13 years).

PROFESSIONAL EXPERIENCE

Oct 98 to April 2011 Retired by this company on April 8, 2011

Stellartech Research Corporation SENIOR QUALITY ENGINEER 1350 Bordeaux Drive, Sunnyvale, CA 94089 Class II & III R&D through Manufacturing Radio Frequency, x-ray and other medical devices developed for customers. 

Responsible for and authored 510(k)s, wrote for team to obtain TUV Safety Mark CE and Technical Files, UL Certifications, and CSA Safety Marks for Radio Frequency medical devices. 

Authored: User Manuals/Instructions, reviewed/corrected/ approved Hardware and Software V&V documents, D&D plans, Quality Plans, created and maintained Design History Files for multiple customer medical devices development.

Participated on design review teams.

Maintained Manufacturing Authorization and Rework Record Log and follow up files to ensure closure of these records in a very timely fashion.

Selected accomplishments:

·   Got 8 successful 510(k) submissions approved by U.S. FDA for Stellartech Research Corporation and some customers.

·   Created Technical Files/Design Dossiers for CE Mark for medical devices and disposables.

·   Created documentation and helped team to get RWTUV, TUV Nord, TUV Rhineland Safety Marks, ETL/Intertek Safety Marks, CSA safety marks and UL certifications

·    Manufacturing Authorization (MA) and Rework Records (RO) Gatekeeper – reduced errors by 85% to 90% and followed up on closure of the MAs & ROs.

Oct 96 - Jul 98

Fidus Medical Technology Corp. SENIOR RA / QA ENGINEER Fremont, CA. Start-up Class II & III cardiac microwave medical device R&D Company.

Responsible for all QA, QC, RA and Reliability: implementation of FDA QSR, EU CE Mark 998 and ISO 9001, EN 46001 systems and procedures; all HFA submission actions to Canadian HPB and U.S. FDA including animal and domestic & international clinical trials, wrote and got IDE and 510(k) approvals, and validations.

Held collateral duties as CALIBRATION COORDINATOR, U.S. CUSTOMS LIASON and INSURANCE LIASON.

Managed, trained, coordinated and scheduled one Quality Engineer, one QA Specialist, and two Quality Technicians. Participated on design review teams.

Selected accomplishments:

·    Improved Regulatory documentation quality for 510(k) for intra-operative device, Case Report Forms, clinical and animal trial protocols, wrote FDA IDES for AFL & Right Sided AFib, Instructions for Use, FDA and Canadian HPB letters.

·   Created CE Mark Quality Evaluation Plan, Clinical Monitor Package, Design Dossier SOP & Checklist, EU Clinical Trials requirements document, Medical Devices Vigilance System SOP & List of Competent Authorities, and Technical File SOP & Checklist, among others.

·   Coordinated clinical info retrieval from United States, Canada, England, France, Germany and Portugal; acted as Monitor for 10 animal trials and 5 clinical studies in the U.S.

Dec 94 – Oct 96

MedaSonics, Inc., NeuroGuard, Inc.: spin-off of MedaSonics, SENIOR QUALITY ENGINEER 12- 94 to 10-96 Fremont, CA. ISO 9001, EN 46001, CE Mark MDD 1996 Registered Class I and II ultrasound medical devices. R&D to manufacturing Company.

INTERNAL AUDIT TEAM COORDINATOR: 12-94 to 6-96.

QE & RA - provided ISO 9001, EN 46001, CE Mark, regulatory and safety inputs to Environmental, Hardware, Mechanical validations for 3 diagnostic systems and 10+ Software validations.

Sustained IS0 9001, EN 46001, CE Mark 1996 EMC and 1996 MDD registration maintenance.

Internal Audit Team: managed 15 members Internal Audit Team through EN46001 and 1998 EU CE Mark registrations.

Trained new employees on FDA, ISO9001, EN46001 and CE Mark.

Authored CE Mark Quality Evaluation Plans.

Participated on design review teams.

Selected Accomplishments:

·   Designed & implemented highly successful tabular layout for Medical Device Directive (MDD) Annex 1 Essential Requirements questions vs. replies that greatly impressed the CE Mark Auditor & gained final EU MDD CE Mark 1998.

·   Ran the CAPA System: Improved accuracy and timeliness of Corrective and Preventive Action System - CAPA - by at least 70% by improving filtering, and getting management support to appoint the appropriate owners for Corrective Action Requests.

·   Awarded MedaSonics Quality Recognition for Software Validation Procedures developed from marketing specifications and turning them into excellent, effective validation procedures, Freed up the software engineers to develop new features and products.

·   Initiated three-member review board for previewing all Document Control Requests because of previous poor technical submissions resulting in poor quality and reliability of instrument systems. My reviews reduced technical and other errors by 95%.

June 82 - Oct 94

Syva Company, Instrument Division, QUALITY ENGINEER III (12-88 to 10-94); QUALITY ENGINEER II (6-82 to 12-88) MTN .View, CA. Class II in-vitro medical diagnostic R&D to manufacturing company. 

Supported QC OEM in development and manufacturing facility; QC RI, QC WIP, Factory Repair, Production floor for 6 diagnostic systems.

Regulatory design validations for CSA, VDE.  

Reviewed Syva and OEM software validations for 10+ software releases.

Authored Quality Evaluation Plans to regulatory requirements.

Participated on design review teams and MRB teams.

Selected Accomplishments:

·   Review of Software Validation documents brought quality levels up 300% for OEM and Syva Development by substantially reducing the number of errors.

·   Authored excellent QA procedures which where used as training tools, ensured highly efficient Final QC inspections and greatly facilitated subsequent ISO 9001 registration.

·   Chair of Safety Committee: 1989 & 1990. Managed low-key commitee to a highly visible, active, and effective body and greatly increased workplace safety.

Mar 80 - Jun 82

Delta Associates, RESEARCH EVALUATION ENGINEER.  Milpitas, CA Start-up computerized Gas Chromatograph R&D to manufacturing company. Prototype through production support of a new computerized gas chromatograph.

Supervised two test technicians.

Regulatory duties as RADIATION SAFETY CHAIRMAN and MANUFACTURING SAFETY OFFICER.

Selected Accomplishments:

·  Designed and implemented Gas Chromatograph testing station and

·  Designed and implemented Gas Chromatograph testing laboratory once Delta Associates was brought into Spectra-Physics in 1982.  

   ·  Junior Achievement Recruiter – got record numbers of students in two Milpitas, CA high
  schools to join Junior Achievement in talk given to classes there in.

Jun 75 – Feb 80

U.S. FOOD AND ‘DRUG ADMINISTRATION ANALYTICAL CHEMIST GS 5 to GS 11-2. San Francisco District Office (SAN-DO).

Analyses Foods for chemical contamination and insect infestation.  Analyses drugs for content and uniformity. 

Served on Consumer Affairs detail addressed telephone public questions on FDA. Interviewed on local radio show on FDA topics.

Served on Investigations detail inspected food and medical device companies in San Francisco Bay Area. 

FDA Speakers Bureau – gave talks to junior college classes, professional organizations and general public on FDA and Food and Drug safety, food additives, etc. Jan 75 to Jun 75

Jan 75 to Jun 75

U.S. Consumer Protection Agency Analytical Chemist GS-5  50 Fulton Street San Francisco, CA

• Analyzed consumer products for safety with wet chemistry and scientific instrumentation.

Nov 73 to Jan 75

Diamond Shamrock Chemical Co. GC-Mass Spectometer Technician. Redwood City, Calif. 94063

• Analyzed one of the NIOSH 17 carcinogens Bis(chloromethyl) ether by GC-MS.  It was a by product of one of the Ion Exchange resin processes.  It was captured on air sampling tubes with air pump worn by the manufacturing technicians. 

Aug 73 to Nov 73

ULTRACHEM CORP  Analytical Chemist 1150 CIVIC DR WALNUT CREEK, CA 94596-8241

• Analyzed various chemical products, collected and analyzed stack gases at industrial sites for environmental impact - by wet chemistry  and scientific instrumentation.

EDUCATION

·   MSc Quality Assurance, GPA 3.81 - San Jose Sate University 1989. San Jose, CA: Master's Thesis: An Effective Quality Evaluation Plan for Start-up to Small Scientific Instrumentation Companies.

·   BSc Chemistry, cum laude - San Francisco State University 1973; San Francisco, CA. (60 semster hours in Chemistry)

·    AA Quality Assurance, summa cum Iaude - De Anza College 1986; Cupertino, CA.

·    Certificate in Management & Supervision, GPA 3.82 - Mission College 1981; San Jose, CA.

·    AS Chemistry GPA 3.25 - City College of San Francisco 1971; San Francisco, CA.

SKILLS

1.  Application, enforcement and interpretation of Federal Regulations and simplifying them into training documents and procedures: cGMP, various Codes of Federal Regulations - Fidus, MedaSonics & NeuroGuard, Syva, USCG Reserve, FDA. (21 years).

2.  Public Speaking: USCG Reserve, Church Lector, FDA Speakers Bureau, Junior Achievement, Toastmasters. (15 years)

3.   Team Player examples

Ø  USCGR: 6 Meritorious Team Awards for Marine Firefighting Contingency Plan, Area Environmental Contingency Plan, Port Outload and Security Plan, (18 years)

Ø   MedaSonics & NeuroGuard: implementation of ISO 46001 and EU MDD CE Mark; and Internal Audit Team Leader with Team contributions to corrective action and process improvements. (4 years)

Ø  ASQ: San Francisco Section 0604 – Section Chairman (1991-1992) Successful management program improvement increased San Francisco Section to Master Section level during my Chairmanship (1 year - plus held all section positions from 1983 to 2006 – 23 years)

4.  Technical Writing: Stellartech Research Corporation, Fidus Medical Technology, MedaSonics & NeuroGuard, Syva, Delta Associates, CG Reserve, ASQ.(36 years)

MILITARY

Oct 78 - Jan 97

U. S. COAST GUARD RESERVE: PS3 E4 to Senior Chief E8. PORT SECURITYMAN: Served as

MARINE SAFETY BOARDING OFFICER;

PORT SECURITY PLANNING SPECIALIST and

MARINE FIREFIGHTING CONTINGENCY PLANNING SPECIALIST:

District 11; ASSISTANT TRAINING OFFICER for 95 people;

CURRICULUM COORDINATOR for 95 people;

MARINE INVESTIGATOR: performed investigations of marine accidents;

MARINE INVESTIGATIONS DEPARTMENT HEAD: managed and scheduled 9 Marine Investigators doing marine accident investigations;

INSTRUCTOR – designed and taught multiple classes.

·    CERTIFIED MARINE SAFETY BOARDING OFFICER: regulatory application, enforcement and interpretation of 33CFR, 46CFR, 49CFR, IMO, U.S. Codes and U.S. Codes Annotated – (5 years) experience. Was the first USCGR member to obtain this certification.  Designed and published Marine Safety Boarding Officer hand book – 16 years experience

·    CERTIFIED MARINE INVESTIGATOR: regulatory application, enforcement and interpretation: 33CFR, U.S. Codes and U.S. Codes Annotated - 2 years experience.

USCGR Schools attended

·   Instructor Training (first in class) (2 weeks)

·   Port Securityman Basic (first in class) and Advanced |Schools (4 weeks).

·   Marine Environmental Response Basic (first in class) and Advanced Schools (4 weeks) & HAZWOPER course (2 days)

·   Reserve Senior Petty Officer Leadership and Management  (first in class) (2 weeks)

Jun 1965 – Jun 1971

U.S. SUBMARINE RESERVE, SR E1 to E5, TORPEDOMAN’S MATE Striker TMSN(SG) to TM2(SS), Qualified in Submarines on USS Diodon (SS-349) a diesel electric submarine during active duty (Feb 67 to
Oct 68).  Navy schools attended:

·    SP/SG Submarine School Reserve (Jun 65 to Aug 65)

·   Basic Electricity Electronics Prep (BEEP) School, NTC San Diego, CA 6 weeks accelerated pace (Jun 66 to Aug 66)

·   Torpedoman’s Mate “A” School, Fleet ASW School, San Diego, CA 8 weeks – first in class (Aug 66 to Sept 66)

PUBLICATIONS -  Chapters - Pharmaceutical Quality Management & Healthcare Quality Management - In the Quality Management Handbook, 2nd Ed. Revised and expanded. Marcel Dekker, 1997

Your Web Master's Parents in late 1945 just before getting married

My Generation - Your Web Master
Songs & Videos
Updated 07-24-11

Jesus, Lover of my Soul!
Borne Again Christian Songs & Videos
Updated 08-04-11
 

Come Now is the Time To Worship-Brian Doerkson and Wendy O'Connell

Updated 05-22-11

Your Web-Master's Military Experiences

Military & Patriotic Orgs I belong to

Your Web Master's Life Member NAVetUSA Web Page

 

James R. Santos 1965 to 1971 SR, SA, SN, SN(SG), TMSN(SG), TMSN(SS), TM3(SS) to TM2(SS) USN Submarine Reserve 06/1965 to 06/1971 TM Torpedoman's Mate Your Web Master in his TM days Torpedoman's Mates in Action - Stories & Photos Submarines Your Web Master served on Your Web Master's Life Member NAVetUSA Web Page Your Web Master in his TM days Your Web Master as TM2(SS) in 1969 Here is your Web-Master on USS Diodon (SS-349) in September 1967 in Hong Kong, BCC.  That is an Australian frigate's bow seen in the background. Back then on Diodon Submarine Qualification Certificate of James Richard Santos, TNSN(SS) (New 04-17-07) USS Diodon (SS-349) Home Port without Frames - for Diodon Shipmates, Photos, History This photo was taken, as I recall, on board one of those covered Coaxain's Boats. This was just after i had completed a week end working in the Torpedo Shop on the Sub Tender USS Sperry or USS Nereus. Another Reservist from my Submarine Reserve Unit, TM2(SS) Ruiz. I believe, snapped this photo.  He was a photographer by trade, as I recall. He took the photo as we were returning to shore from the tender, which was moored out in the water at Fort Roscrans, Ballast Point Submarine Base, San Diego, California.   USNR My Training & Advancement       SR Seaman Recruit   1965    SA Seaman Apprentice   1965  SN Seaman Actually TMSN(SG) 1966 TMSN(SS) in 1967  TM3(SS) Torpedoman's Mate Third Class 1967  TM2(SS) Torpedoman's Mate Second Class 1968 Bluejacket's Manual Sixteenth Edition 1962   Basic Military Req'ts NAVPERS 10054-A 1965   Seaman NAVPERS 10120-D   1965   Petty Officer 3 & 2 NAVPERS 10056-A 1966   TM 3 & 2 NAVPERS 10163   1967  USN Service Stripe:  1 for each 4 years (6 years total) 1 x (New 05-13-11)

 

James R. Santos

1978 to 1997

U.S. Coast Guard Reserve

PS3 to PSCS USGR Ret.

US Coast Guard Reserve 10/02/78 to 01/01/97

PS

Port Securityman

Coast Guard Rating Video PS

My USCGR PSCS Uniform Coat
with Submarine Qualified Dolphins, service years Hash Marks, awared Ribbons, USCG Name Tag, Port Securityman Senior Chief  (PSCS) Chevron

PS3, PS2, PS1, PSC, PSCS

Service Stripes:  1 for each 4 years (6 years USN Sub Reserve, plus 18 years, 3 months with USCGR = total 24 years, 3 mo) 2 x 6 x

(New 05-13-11)
 

U.S. Coast Guard

Coast Guard celebrates 215 years of service to U.S.

The History of the U.S. Coast Guard film

The USCG Chief's Call Web Site

Your Web Master circa 1986 to 1988 as Chief Port Securityman, USCGR

Your Web Master circa 1986 to 1988, as Chief Port Securityman, USCGR, with his sons

Your Web Master's USCGR Desktop Name Plate as PS Senior Chief

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