Quality Assurance Manager

sid sanchez

***** ******* **** ( San Antonio, TX 78230 ( 210-***-**** (

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

quality mgr /Quality Engineer. /Operational Excellence ENG. / Black Belt

Eng

Implementation of the Quality Control and Quality Assurance departments.

Implementation, Mentoring and Leading of Green Belts and Black Belts.

Implementation, monitoring and maintenance of ISO systems: 9001, 16949,

13485 and 14000.

Implantation, mentoring of Lean Manufacturing Systems

Skills

PROJECT MANAGEMENT Fabricator of Electronic Instron / Chatillon /

Performance Management Equipment Pull Testers

Quality Systems Audits Wave Soldering

Best Practices QA / QC / Incoming / Final Supplier Quality Liaison

Program Cell Design

Metrics/Trending Internal/External Audits Continuous Improvements

DMAIC/PDCA Team leadership/Motivation Preventive Actions

Kaizen Regulation/Compliance / SOPs Corrective Actions /CAPA

Cost Reductions Data Analysis / Minitab 16

Poke-Yoke MS Office/Excel/Project Test Methods

Design Assurance SIPOC Out-of-box auditing

Risk Assessment Supplier Quality Plans Batch Records

ANSI/Mil-Std Sampling Contract Manufacturing New Product

plan Solid Works Introductions

MRB/RMA/FAI Cell Design Design of Experiments

Non-destructive Tests SPC PPAP/APQP/CP/FMEA/MSA

Fixture Design Reduction of process variation FDA

Scrap Reduction RGA

One piece flow Microsoft Office 2013 /

VISIO

Value Stream Mapping

MANUFACTURING AREAS

Assembly Metal Stamping Verification &

Plastics Wires Manufacturing Validation

Medical Devices Mentoring / Training Wave Soldering

Clean Rooms Cell Design Extrusion

R&D CNC Risk Management

Pharmaceutical Calibration Test Methods

SMT Test Equipment Reliability

Electronics Kaizen Metrology

Poke -yoke Kanban Gage / Fixture Design

SPC Machining TPS - Toyota Production

System

EPS /Aluminum Injection

PROFESSIONAL EXPERIENCE

Ethicon / Johnson & Johnson / BEPC March 2013- Present

San Angelo, TX

Process Excellence Engineer 2

Implementation and coaching of several Manufacturing Systems: Lean

Manufacturing, Black Bet, Kaizen, ISO systems, Medical Devices, Cell

Designs, Training programs, Cost reduction, Reduction PPM's, Plant Start

-up or Plant Expansions, Set up new departments, Laboratories, Weekly

presentations, FDA, ASTM, Implementation of process controls / Statistical

such as: SPC, DOE, Operational Excellence activities in the business, Clean

Rooms, Sterilization, Batch control and Manufacturing floor etc.

KCI / BEPC May-2013 to February-2014

San Antonio, TX

R&D and Corporate center for Medical Devices

Verification & Validation Engineer 2

Lead team of technicians and test engineers for verification of Medical

Devices. Black Belt Projects, Scheduled testing activities in Europe and

USA for various design verification time points of system, subsystem and

components (electro-mechanical-SW integration). Developed test protocols

and test reports in conjunction with Design, Development, Test Methods,

Work Instructions, Quality Assurance, Regulatory, CAPAs, FDA, Black Belt

projects, Manufacturing, Supplier Development, Heavy Data Analysis, and

Marketing strategies, Supervising six Laboratories, Equipment validation,

Bench Test, Medical devices testing and Batch Control and FDA regulations.

UCEVERSITY / BEPC January 2013 to May

/2013 McAllen, TX

This position provides accessory, coordination implantation and monitoring

of Black, Green Belt Projects, Lean Manufacturing, ISO systems, General

Manufacturing Consulting and coaching to all levels.

GW PLASTICS INC October 2006 to December 2012

San Antonio, TX

Manufacturer of plastics molding products, silicon, assemblies,

pharmaceutical, Medical and Automotive products.

Quality Assurance Manager

This position provides coordination, implementation, supervision and

development of the Incoming Inspection, quality Control, ISO 9000

Activities, QA Laboratories and Quality Assurance departments, Management

Representative, Customer main contact, Continuous improvement and

preventive actions, Implementation, monitoring and maintenance of Quality

Systems: 90001,16949,13485 and 14000.

Key Results:

. Implementation of the ISO13485 (Medical Sector) in one year

. Validation of 10 projects in 10 months.

. Management Representative (Customers, Audits and New customers)

. Excellent Results on the External ISO Audits (0 nonconformities) in

several years

. Implementation of continuous improvement projects : 2-3 per month

. Implementation of preventive action projects: 4 -6 per month

. Installation of four clean rooms in 11 months.

. Implementation of the CGMP & 21 CFR part 820.

. Validation of different medical devices in 6 months.

. Value Stream Mapping implementation

. Implementation of the Risk Management system.

. Multi-plant Support (Queretaro Mexico, Tucson, Puerto Rico & Vermont

plants)

. Performed Audits (Corporate, Sister plants, Internal and Suppliers)

. Develop, coordination and presentation (Management Review, department

budgets and production indicators)

. Implemented 5 'S" and Kaizen Methodologies

. Supported 12 projects with the R&D corporate & customer group

. Institution of the SPC, special instructions and designed special

gages.

. Design and Implementation of Poke Yoke systems

. Trained: Department Managers, Quality Engineers, Technicians and

Operators

. Implementation of the Incoming and final inspection departments

. Reduction 80% of customer complaints from nine consecutive negative

months/ score cards in four months.

. Created and communicated a new vision for the Company, focused on Lean

and 5"S" driven operations, total quality management.

. Improved the on time delivery by elimination of rework products,

elimination of repetitive activities, improved maintenance programs,

elimination of repetitive defects, pricing, improve the packaging,

etc.

Uceversity Black Belt 1/2013 - 5/2013

McAllen, TX

GW Plastics Inc. QA Manager 8/2006- 12/2012 San

Antonio, TX / Vermont, VT

Futaba / Toyota Group Asst. QA Manager 8/2005 - 8/2006 Nagoya,

Japan /San Antonio, TX

Uceversity Black Belt 1/2000- 8/2005

McAllen, TX

Universal Metal Products QA Manager 1/2004 - 4/2005

Pharr, TX / Wickliffe, OH

Invensys / Ranco OEM QA Manager 4/1999 - 1/2004 Brownsville, TX

/ pAIN cITY, oH

Plastics Engineering Cts QA Manager 6/1995 - 4/1999

El Paso / McAllen, TX

Security Plastics West Sr. QA Eng. 7/1993 - 6/1995

Miami, FL / McAllen, TX

Kimball Electronics Mfg Eng. 1/1990 - 7/1993

Jasper, In /Reynosa, Mex.

Whirlpool Co. OEM Industrial Eng. Mgr 12/1986 - 12/1989 Benton

Harbor, Mi /Monterrey, Mex.

Education & Certifications

. BS IN INDUSTRIAL ENGINEERING (IE) -REGIOMONATANA UNIVERSITY - 1991

. BS in Industrial Engineering (IE) -Cambridge State University- 1998

. Master in Business Administration (MBA) - Columbus University - 2005

. Electronics Service Technician (EST) - Detroit, Michigan -1992

Specialized Training & Main Certifications

Six Sigma Black Belt - INVENSYS OEM -2003

Six Sigma Green Belt - INVENSYS OEM -2001

Certified Quality Technician - ASQ -1995

Certified Quality Engineer - ASQ - 2011

Certification in APICS / CPIM - 2012

ISO Auditor certified - ISO9000,16949, 13485 & 14000

TPS Toyota System - Trained in Japan / Futaba Industrial / Toyota Group -

11 Months

Risk Management

OSHA certification

CGMP @ 21 CFR part 820

Lean Manufacturing - Brownsville University

DOE - Air Academy - San Antonio, TX

Calibration/ Metrology - Mitutoyo

Color appearance seminar by TRW

Advance Corrective actions - FORD, Maytag and Chrysler.

RAM optical, FARO and CMM

Melt Flow Analysis

Verification & Validation & Test Methods

Cell Design - Toyota

AS9100 certified

Customer Awards

. Best KAIZEN AND CELL DESIGN & PPM Reduction - Toyota 7/2006

Nagoya, JAPAN

. Best Supplier Customer Service and PPM Reduction - TRICO 6/1999

Brownsville, TX

. Best Supplier of 64 suppliers PCB / Assy - IBM/Lexmark 7/1992

McAllen, TX

References Available upon request.

Contact this candidate