Certified Quality Engineer/Auditor/IPC Specialist

Patrice L. Wilson CQE/CQA/CIS

*** ******* ******, *********, ** 94550

925-***-****, **********@*****.***

CERTIFIED QUALITY ENGINEER (American Society for Quality, #57657, Jun 2011)

CERTIFIED QUALITY AUDITOR (American Society for Quality, #40971, Jun 2010)

CERTIFIED IPC SPECIALIST, IPC-A-610 (Service to Mankind, #610MS 38 522211,

Mar 2013)

PROFESSIONAL SUMMARY

I have a proven track record in coordinating and participating in root

cause / corrective / preventive action activities CAPA, and driving defect

levels down. I have a proven track record in understanding the Customer's

needs / concerns and bringing the Customer focus to the appropriate

internal folks and Suppliers. I also have experience working with

Suppliers, with teams developing and releasing new products to

Manufacturing, and with Quality Management System support. I am a Certified

Quality Engineer/Auditor, Certified IPC Specialist for Acceptability of

Electronic Assemblies, and Member (#00254528) of the American Society for

Quality. My strongest skills are writing reports and procedures as part of

the Improvement / Audit / CAPA activities, adherence to metrics,

implementing preventive actions, and acting as a Customer advocate.

RELEVANT SKILLS

. Quality / Business Improvement / Regulatory Initiatives and Product /

Process / Operations Excellence.

. Internal auditing per company processes and procedures, QSR

(21CFR820), ISO 9000:2008, and ISO 13485.

. Root Cause Analysis, Corrective Action, and Preventive action

activities for Internal Discrepancies and Customer returns.

. Process/Product Problem Solving activities with Multifunctional Teams

that work on improvements in product function, operator training,

equipment calibration and maintenance, product handling/flow, and

process documentation.

. Developing metric packages designed to monitor Quality levels, trends,

defect paretos, and tracking improvement actions taken.

. Use ECO / Document Control systems to develop processes / procedures

for evaluating product Quality and initiating improvement activities.

. Working with Teams introducing New Products to the Manufacturing

floor.

. Customer, Supplier, Original Equipment Manufacturer, and Contract

Manufacturer Quality Engineering experience for a variety of

industries.

. Incorporate SPC, PFMEA, 7-Step/8D Problem Solving, Quality metrics, 5

Whys, and Fishbone diagrams, in process/product improvement and root

cause / corrective action activities.

. Strong written and oral communication skills with excellent computer

and people skills. Able to act as a liaison between the Production,

Engineering, Management, Suppliers, and Customers.

PROFESSIONAL EXPERIENCE AND ACCOMPLISHMENTS

Manufacturing Engineer, Entegee Engineering Technical Group, New Hope, MN

(9/2011 to 10/2012).

. Temp assignment with Boston Scientific, Fremont, CA in the Supplier

Engineering group. Temp assignment completed.

. Worked with suppliers to obtain Component Material Assessments

(CMAs) and evaluated the returned data for Regulatory / company

requirements. Supported CMAs for 5 different product lines.

. Performed analysis on CMA data to qualify the components for new

product lines and old product lines being offered in new locations.

. Used the Product Data Management (PDM) system to initiate and

structure component CRs (Change Requests) and post the CMA data to

the company database.

. Interfaced with the R&D Engineers, Suppliers, Manufacturing

Engineers, Purchasing, Regulatory Affairs, and Incoming Inspection

groups to resolve CMA issues.

Quality Engineer, Aerotek, San Ramon, CA. 4/2009 to 9/2009.

. Temp assignment with AccSys Technologies, Inc., Pleasanton, CA.

Temp assignment completed.

. Resurrected the Quality Management System (QMS) and GMP

documentation. This included auditing processes to determine

current practice and updating or creating all GMP procedures and

forms.

. Updated and implemented the calibration program for all tools used

in the manufacturing process.

. Updated the Internal Audit program to verify whether business

activities comply with the GMP and other internal procedures.

. Coordinated the employee GMP training activities as a part of the

updated QMS implementation.

Quality Engineer, CTS Corporation, San Jose, CA. 4/2008 to 1/2009.

. Coordinated the Calibration and Microscope systems to ensure

equipment is pulled and serviced in a timely manner.

. Chaired the MRB to ensure dispositions were made in a timely

fashion.

. Interfaced with Suppliers and Customers regarding root cause

corrective action activities for Non Conforming material, RMAs, and

CARs.

. Used 8D methodology to review and answer SCARs, ICARs, and CCARs.

. Supported

. Developed metrics for presentation to Customers, Suppliers, and

Internal Personnel.

. Performed Internal Audits to ensure compliance to ISO9000:2000 /

13485 requirements and updated, rewrote, and developed SOPs to

address audit non conformances and reflect current operations.

Quality Engineer, Coast Personnel, San Jose, CA. 4/2007 to 6/2007.

. Temp assignment with Sanmina-SCI, Enclosure Division, Fremont CA.

Temp assignment completed.

. Interfaced with Customers during source inspections. Incorporated

the Customers concerns in root cause / corrective action

activities.

. Maintained metrics and reported the results to the appropriate

internal and external parties.

. Reviewed Final Inspection Checklists against the Customer Drawings

and Specifications. Updated and in some cases rewrote the

checklists to ensure compliance with the requirements. Reviewed

the updated checklists with the inspection / production folks to

facilitate training.

Quality Engineer, Memry Corporation, Menlo Park, CA. 5/2005 to 9/2006.

. Coordinated the analysis, disposition, processing, and corrective

actions for Customer Complaints, RMAs, and Internal Corrective

Actions.

. Chaired the MRB meetings to ensure timely dispositioning,

processing, and closure of Non-conformances.

. Set up Quality metrics to monitor First Pass Yield and Defect

Paretos.

. Chaired a Quality Improvement Team tasked with the responsibility

for reviewing all Work Instructions, obsoleting or rewriting the

Work Instructions to reflect current practices, and training the

appropriate personnel using the updated Work Instructions.

. Coordinated the purchase, development, gage R&R, work instructions,

and training for the Ultrasonic Thickness and Bend to Free Recovery

(Transformation Temperature) inspection gages.

. Developed and programmed (in to the Access database) Inspection

Test Masters to incorporate both internal and external

specification and drawing requirements.

Quality Engineer, Superior Technical Resources, San Jose, CA. 8/2004

to 1/2005.

. Temp assignment with KLA-Tencor, San Jose, CA. Temp assignment

completed.

. Performed queries on the Non Conformance database, set up metrics

to monitor defect levels and types, and coordinated Non Conformance

review meetings to determine actions required to resolve the issues

and drive improvement.

. Uncovered a major bug in the data collection system that was

hampering the integrity of the metrics.

. Performed Plant Compliance audits on product ready for shipment to

the customer.

. Developed, flowcharted, documented, and implemented a paperless

process/procedure for Incoming Inspection of the reticles (masks)

used to qualify the product.

Quality Engineer, Sun Microsystems, Newark, CA. 8/2000 to 8/2004.

. Chaired Multifunctional Teams in improvement activities for three

product lines.

. Participated on a team responsible for the introduction of two new

products from the New Product Introduction phase, through release

to General Availability, to Sustaining status.

. Developed the QA metrics for three product lines covering 20

products. Updated and presented these metrics to the

Product/Process Engineering, Management, and Work Cell Teams at

Weekly, Monthly, and Quarterly Quality Improvement meetings.

. Coordinated Process Improvement activities with Product/Process

Engineers and Work Cell Teams to reduce defect levels, increase

process efficiency, reduce costs, and improve cycle time.

. Conducted monthly process audits for my product lines targeted

towards process improvement and compliance.

Quality Assurance Engineer, Galgon Industries, Fremont, CA, 6/1997 to

8/2000

. Performed and coordinated the dispositions, failure analysis, root

causes and corrective actions for all customer returns.

. Uncovered a design flaw with one of the components that was a

significant contributor to the defect rates.

. Compiled the weekly, monthly, and quarterly quality metrics.

Presented these results to suppliers, customers, management,

engineering and floor personnel.

. Coordinated the development of the internal defect tracking system

and presented the weekly results.

SPECIAL TRAINING

. Certified IPC Specialist, (Service To Mankind, IPC-A-610), #610MS

38 522211, Mar 2013

. Introduction to the Biomedical Industry (ASQ - Silicon Valley,

Course B101), Sunnyvale, CA 10/2012

. Managing CAPA, NCMR, Deviation (ASQ - Silicon Valley, Course B108),

Sunnyvale, CA 09/2012

. Supplier Management (ASQ - Silicon Valley, Course T107), Santa

Clara, CA 08/2012

. Process Capability Analysis (ASQ - Silicon Valley, Course T106),

Santa Clara, CA 03/2012

. Measurement Systems Analysis (ASQ - Silicon Valley, Course T102),

Santa Clara, CA 03/2012

. Quality Conference "On the Road to Performance Excellence"

(American Society for Quality), Santa Clara, CA 10/2011

. Certified Quality Engineer #57657 (American Society for Quality),

Santa Clara, CA 6/2011.

. Document Control & Records Management (ASQ - Silicon Valley, Course

# 625), Sunnyvale, CA 10/2010.

. Risk Management (ASQ - Silicon Valley, Course # 611), Sunnyvale, CA

7/2010.

. Process Validation (ASQ - Silicon Valley, Course #605), Sunnyvale,

CA 6/2010.

. Certified Quality Auditor #40971 (American Society for Quality),

Santa Clara, CA 6/2010.

. Design Control (ASQ - Silicon Valley, Course #612), Newark, CA

12/2009.

. Value Stream Mapping (ASQ - Silicon Valley, Course #624), Newark,

CA 10/2009.

. Lean Manufacturing (ASQ - Silicon Valley, Course #608), CA. Newark,

10/2009.

. Quality System Regulation (ASQ-Silicon Valley, Course #602), Santa

Clara, CA. 9/2009.

EDUCATION

Bachelors in Biological Science, University of California, Santa

Barbara, CA.[pic][pic][pic]

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