Quality Management

Omar Gonzalez

*** *.* ***** ***.; # ***., Miami, FL. 33172

Home: 786-***-****, Cell: 786-***-****, email:

abnb43@r.postjobfree.com

OVERVIEW:

Results-oriented Quality Engineering professional with a Mechanical

engineering experience in manufacturing environments for advance technology

systems. Diverse experience includes Supplier Quality Management programs

in the Medical Device industry, and Quality Assurance Engineering.

Searching for a challenging position where I can contribute with my

experience and knowledge.

AREAS OF EXPERTISE:

o Statistical Control Systems and Measurement Systems

o Supplier Management Programs

o Change Management

o Supplier Corrective Actions/Preventive Actions (CAPA)

o GMP's, ISO 13485, ISO 17025, and FDA Regulations

o Over nine years of medical device experience

o Product and Process validation requirements

o Seven years of automotive industry experience

o PPAP and First Article Requirements

o Major exposure to Six Sigma methodologies/DMAIC techniques

o ANOVA Gauge R&R's

o Product Design and Development

o Root Causes Failure Analysis and Investigation

o Advance Product Quality Planning and Control (APQP)

o Potential Failure Mode and Effect Analysis (FMEA)

o Supplier Management, sourcing and validating (IQ, OQ, PQ)

PROFESSIONAL PROFILE:

> In-depth knowledge of the latest principles, practices, and

methodologies offering over 18 years of solid technical expertise in

the development and implementation of Quality/Supplier Management

Systems Programs and processes based on ISO 13485 and GMP's

regulations.

> Skilled in all areas of quality circles tools (e.g.; DMAIC, Continuous

improvement programs, Decision Trees, Fishbone Diagrams, Cause Effect

Diagrams, Fault Tree Analysis, Ishikawa Diagrams, histograms & pareto

charts, statistical process control and quality cost reduction

analysis programs)

> Highly organized, technically skilled and able to communicate

successfully with operations as well as corporate associates in order

to attain company growth, diminish costs, and assist the organization

in attaining a greater market share. Strongest asset is the ability to

work well under strenuous pressure.

> Strong background in components to include design, development, and

manufacturing. Extensive knowledge of engineering drawings and their

application. Ability to accurately assess situational defects and

effectively determines corrective action paths

> Masters degree in Engineering with an emphasis in automation of

equipment (Mechanical Engineer)

> ISO 9001:2000 (13485) Certified Lead Auditor & ISO/IEC 17025:2005

Auditor

PROFESSIONAL EXPERIENCE:

Sr. Supplier Quality Engineer

April 2000 to Present

Boston Scientific Corporation

Miami, FL

. Responsible for managing all New Product Introduction (NPI) supplier

strategy and quality matters of the GuideWire product lines in the

Miami facility.

. Responsible for supporting plant team product transfer from Miami

operations to Costa Rica plan as a corporate global strategic

initiative. (1.5MM Capita Budget)

. Develop incoming inspection procedures; support incoming material

inspection and problem resolution with vendors. Interface with vendors

to correct problems dealing with purchase materials and Measurement

Equipment devices correlation.

. Manage quality performance and qualification process for suppliers in

the Miami plant

. Manage the ongoing supplier auditing and certification program for the

Miami facility.

. Developing and managing new supplier scorecard metrics, data

collection system, and new SCAR process feeder system into corporate

CAPA.

. Managed Supplier Management Program by developing and implementing

strategic initiatives in order to enhance systematic quality

management plans for both new and existing products. (750 K/Year

Savings)

. Drive continuous improvements through the use of practical, lean

manufacturing methodologies and statistical tools.

. Performs supplier audits and manage suppliers corrective action

request (SCAR)

. Successful implemented SPC on highest cost components yielding

downtime in inspections.

. Interface with divisional R&D engineers and supplied management team

to implement new technologies and new product design.

. Support corporate initiatives for supplier reduction base and cost

savings.

. Support divisional engineering initiatives such as production capacity

increase, tooling evaluation, line transfers and supplier process

changes.

. Managed supplier changes

. Managed supplier audits.

. Responsible for ensuring quality components are supplied to BSC with

zero defects. Responsible for the accuracy and execution of program

timing for purchased components including First Article approval

process development.

. Manage problem suppliers to correct chronic quality issues by ensuring

the implementation of irreversible corrective actions in manufacturing

and quality systems. Accountable for the reduction of yearly

inspection process totaling $325K of savings for purchased components.

. Reduce receiving inspection time by 65% in three years by implementing

supplied data and Dock to Stock programs with vendors.

. Develop and maintain quality plans, statistical process control and

continuous improvement methodologies for new and existing projects in

conjunction with GMP, FDA and ISO 13485 regulations while providing

quality training to all associates.

. Support quality inspectors and ensure procedures are followed to

concrete detail.

. Analyze supplier survey statistics, reject analysis and develop

sampling plans to ensure quality levels are acceptable and

representative of a continuous improving techniques-diagram.

Participated in new product introduction review meeting.

. Participated in product nonconformance to review supplier and

production defects and assure corrective and preventative

opportunities are identified and implemented.

. Routinely conduct rejection analyses, investigating the root cause for

rejects, recommending corrective actions and pursuing them with the

suppliers or other responsible groups until resolved.

. Implement component certification program, which recognize those

suppliers who consistently demonstrate exemplary quality performance.

Quality Assurance Manager

January 1998 to March 2001

Inktel Direct/Towne Inc. (Contract)

Miami Lakes, FL

. Responsible for managing and coordinating the day-to-day business

decisions as it pertains to the Quality Management Group in a

Distribution environment of Valued Added Electronics products and

Collateral Material.

. Implement Quality Control Systems and developed specifications, test

protocols and inspections procedures.

. Responsible for performing and managing quality time study for

improving productivity and performance, enhancing process capability

and increasing customer satisfaction by 15% compared to previous year.

. Develop and maintain procedures in conjunction with ISO 9000

regulations.

. Coordinate and conduct internal and supplier quality audit activities.

. Develop and maintain quality plans, statistical process control and

continuous improvement methodologies for new and existing projects

while providing quality training to all associates.

. Supervise quality inspectors and ensure procedures are followed to

concrete detail.

. Analyze client survey statistics, reject analysis and develop sampling

plans to ensure quality levels are acceptable and representative of a

continuous improving techniques-diagram.

Regional Supplier Quality Manager

Dec. 1993 to January 1997

ABC Group Inc.

Rexdale, Ontario, Canada (Europe and Latin America Sector)

. Directly managed the Supplier Management Program for the European and

Latin American region by developing strategic initiatives in order to

improve quality and reliability of incoming raw materials.

. Responsibilities entailed all business and management decisions for an

integrated group of companies dedicated to the manufacturing of

blow/injection molding components for the automotive industry, and

their valued added in the electronic sector in Spain, Mexico, Brazil,

and the US

. Managing all quality systems activities (set up of quality systems and

their operational forecast, cash flow planning, new projects and

quality planning evaluation, and evaluation of local and foreign

suppliers for raw material.

. Managed and implemented thorough process of certification for 10

companies, assisting them in attaining ISO 9000 and QS 9000

certification process for their Management Quality System and

implementation of the Quality System Requirements (SPC, PPAP, APQP,

MSA, and FMEA).

. Managed initiatives for supplier consolidation

Sr. Q.A. Engineer/Lead Auditor

January 1991 to Dec. 1993

ABC Group Inc

Rexdale, Ontario, Canada

. Effectively represented the Advanced Quality Planning group and

coordinating and implementing policy for controlling Quality

acceptance of procurements to contractual requirements on site and at

Supplier facilities.

. Managing daily activities for the QA department (SPC, PPAP, APQP, MSA,

and FMEA).

. Developed and maintained the quality system for manufacturing of

injection molding components and their valued electronic added process

based on the QS 9000 Requirements for the Automotive and

Telecommunications Wireless Industry.

. Managed the 8D-C.A.R Discipline Problem Solving/Corrective Action

group.

. Supervised and directed the QOS, PPM cost reduction team and supplier

development program, reviewed customer complaints and recommended the

solutions to the senior management team.

. Updated quality management processes and procedures conducted internal

quality audits as well as determining root causes for deviations.

. Provided Quality training on the quality management system as well as

auditing techniques.

PROFESSIONAL COMPUTER SKILLS:

. Operative Systems: Proficient in Microsoft's Windows, Windows

2000/XP, MS-DOS Systems.

. Software: Proficient in Microsoft Office (Excel, Word and Power Point

Presentations, Outlook), Microsoft Project, Visio 2000, SAP & WMS, MRP

Enterprises; Statistical Software: Minitab, Stat-Graphics

EDUCATIONAL PROFILE:

Degrees

B.S., Mechanical Engineering Equivalence Program July 1990 to December

1990

University of Toronto, Comparative Education Service

Toronto, Ontario, Canada

M.S., Engineering August 1984 to June 1990

Moscow State Agricultural University of V.P.Goryachkin (MGAU) Moscow,

Russia

Certificates

AQS Management Systems June 2004

ISO 13485 Certified Lead Auditor

Maple Grove Minnesota

Eastern Michigan University October 1998. Ypsilanti,

Michigan, U.S.A

Team problem solving (8D C.A.R. Problem Solving)

QOS for Operations

Quality Management Institute (QMI) May 1992 &

March 1995

ISO/QS 9000 Certified Lead Auditor Mississauga, Ontario, Canada.

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