Objective:

Obtain a Quality Engineer, QA Engineer, Reliability Engineer, or NPI Engineer where my skills and abilities can be utilized.

Summary of Qualifications:

Over 15 years’ experience in quality assurance: Quality Engineer, QA (Software/Hardware Test) Engineer, and Failure Analysis Engineer, and DVT Engineer. Quality Engineer: MRB, SPC, Metrics, Audits, SOPs, CAPA, SCAR, DMR, FMEA, ECR/ECO Review Surveys (Supplier/Customer/Internal), and Document Control. QA Software Engineer: Black Box, White Box, and UAT testing (Test Plans and Test Reports). QA Hardware Test / DVT / Failure Analysis Engineer: Analyze Customer Returns (Root Cause Analysis). Hardware Test, Software Test, and Product Verification; including, Environmental Testing, Humidity Testing, STRIFE/HALT Testing and Storage Testing. Compliance Verification: UL, CSA, ETL, CE Mark, RoHS, and WEEE. ISO 9001 Internal Auditor, AS 9100 Auditor, and ISO 13485 Compliance Specialist. Write procedures (SOPs) and reports to achieve ISO9001, AS9100 Certification, and CAPA issues.

Demonstrated Ability:

AS 9100 and ISO 9001 Auditor Assessing Compliance to SOPs.

Manage Quality Management System Audits Program.

Manage MRB Processes.

Manage CAPA and SCAR Process; Customer Complaint Investigation, Failure Analysis / Root Cause Analysis.

Metrics: SPC, DPPM, CAPA, and MRB.

Design Verification: FMEA, DFMEA, PFMEA, including UL, CSA, ETL, CE Mark, ROHS, and WEEE Compliance Verification.

Design Validation Testing and New Product Introduction (NPI).

Review and Revise Procedures (SOPs) including Policies, Procedures, and Work Instructions.

Professional Experience:

Abbott Labs, Sylmar, California (11/2021 – 4/2022)

Contract Quality Specialist

Duties: Audit Compliance Management.

Analyze reports and metrics, identify trends and ramifications.

Audit Affiliates and Suppliers for compliance to Regulatory Standards and SOPs.

Review Audits Reports and CAPA responses for completeness.

Assist in CAPA complaint analysis.

Ensure Affiliates and Suppliers are compliant through Supplier Audits, SOP Review, and Audit Reviews.

Achievements:

CRM Abbott Japan assisted in audit review and findings analysis.

Gemalto Inc., Pasadena, California (5/2018 – 4/2021)

Quality Engineer

Duties include Quality Control, Quality Audits, Process Improvement, and Training. Created and maintained manufacturing process flow charts.

Manage CAPA and SCAR Process; Customer Complaint Investigation, Failure Analysis / Root Cause Analysis.

Manage Material Review Board (MRB).

Manage ESD and Calibration Program.

Manage UL, CSA, ETL, CE Mark, ROHS, and WEEE Compliance Verification.

Supplier Quality Management.

Achievements:

Established ESD program (ESD Smocks, Personal ESD Equipment, ESD Procedure, ESD Training, ESD Audits, and Workstation Setup).

Established Kanban Program for Production.

Established Calibration Program for Production, RMA, Quality, and Warehouse.

Improved Production Workstation (Tool improvement, and Kanban Binning Process).

Improved Touchless Fingerprint Scanner, Decorative Green LED Strip. Problem: Units failing at 80% in pre-production. Solution: Changed Production process to have supplier assemble non-essential decorative assembly; improved supplier production process to increase yields above 90 percent.

Zodiac Aerospace, Product Support Division, Garden Grove, California (4/2015 – 5/2018)

Quality Engineer

Duties include Quality Control, Quality Audits, Process Improvement, and Training. Experienced in ISO 9001 practices, and AS9100. Created and maintained manufacturing process flow charts, and SOPs.

Conduct ISO 9001 and AS 9100 Audits.

Manage Material Review Board (MRB).

Manage CAPA and SCAR Process; Customer Complaint Investigation, Failure Analysis / Root Cause Analysis.

Achievements:

Workstation Improvement: Problem: Inspectors making too many errors due. Observation: Near high volume Production environment with inspectors working long hours for 5 – 6 days per week. Action: Reduce workstation clutter and improve flow of goods through inspection; reduce “On-Hold” shipments at workstations.

Magnet Polarity Error: Supplier does not mark parts indicating North and South pole. Replacement parts must match Production assembly. Action: Create ECN to update DWG with North and South pole information; Provide polarity testers to Production and Quality to ensure correct polarity; provide Quality Alert and training.

Sabritec Inc., Irvine, California (1/2014 – 2/2015)

Business Analyst

Duties include Quality Control, Quality Audits, Process Improvement, and Training. Experienced in ISO 9001 practices, and AS9100. Aerospace products.

Create and maintain manufacturing process flowcharts, and SOPs.

Conduct ISO 9001 and AS 9100 Audits.

Manage CAPA and SCAR Process; Customer Complaint Investigation, Failure Analysis / Root Cause Analysis.

Managed Material Review Board (MRB), FMEA, PFMEA, PPAP, and FAI.

UL, CSA, ETL, CE Mark, ROHS, and WEEE Compliance Verification.

Achievements:

Customer Received Damaged Product: Problem: Product connector pins are 4.5 inches long, 100 pins per connector. Note: Specialized aerospace connectors requiring custom packaging. Action: Updated Product Packaging and institutionalized fix by ECN release of packaging changes to the BOM Package.

Management Requirement: All Production and Quality equipment must be UL Certified. Action: Assess all Production and Quality Equipment, and work with Engineering, Suppliers, and UL to update equipment to UL standards.

Teledyne Battery Products, Redlands, California (10/2011 – 6/2013)

Senior Quality Engineer

Duties include Quality Control, Quality Audits, Supplier Audits, Process Improvement, and Training. Experienced in ISO 9001 practices, and AS9100. Aerospace products.

Create and maintain manufacturing process flow charts, and SOPs.

Conduct ISO 9001/AS 9100 audits,

Manage CAPA and SCAR Process; Customer Complaint Investigation, Failure Analysis / Root Cause Analysis.

Manage Material Review Board (MRB), FMEA, PFMEA, PPAP, and FAI.

Audit shipments and provided metric data (KPIs) to management.

Conduct QA evaluations of supplier facilities for quality processes and process capabilities.

UL, CSA, ETL, CE Mark, ROHS, and WEEE Compliance Verification.

Achievements:

Achieved AS9100C Certification.

Created Production Process Flowcharts of the manufacturing process to achieve AS9100 Certification Requirement.

Implemented Risk Management Process into the Production Process to address AS9100 Certification Requirement.

Motorola, Anaheim, California (8/1999 – 12/2010)

Senior Quality Assurance Engineer

Quality Control, Quality Audits, Supplier Audits, Process Improvement (Six Sigma), and Product/Contract Testing. Experienced in ISO 9001 practices (ISO 9001 Internal Assessor). Biometric products.

Create/Manage SharePoint Internal Department websites working with various groups (Accounting, Finance, Marketing, Logistics, Supply Chain, Design Services, Customer Support, Certification and Test) to ensure processes, procedures, forms, and reports are available and meet requirements.

Manage Document Control Process for procedures (SOPs), working with department heads to ensure procedures were kept current. Assisted managers with procedure updates.

Conduct QA evaluations of supplier facilities for quality processes and process capabilities.

Conduct Quality system process and product audits.

Manage CAPA and SCAR Process; Customer Complaint Investigation, Failure Analysis / Root Cause Analysis.

Conduct QA Reviews of Engineering Change Orders (ECO). Write Engineering Change Request (ECR) to address customer requirements, production issues (MRB, FMEA, PFMEA, PPAP, and FAI), and process improvement (CAPA).

Manage Customer Satisfaction Surveys for External Customer Yearly Survey, End of Project Customer Surveys, and Internal Management Assessment Surveys.

Manage LiveScan and Kiosk manufacturing test activities at the supplier.

Manage Ship/No-Ship Reviews driving final problems to closure, summarizing open issue to management, and department heads.

Conduct contract testing for multi-million-dollar contracts. Write test plans, final inspection, and writing final test reports.

Achievements:

Established ROHS, and WEEE Compliance Verification Program achieving 100 percent Product Compliance.

Redesign of LiveScan 2000 Prism to address Customer Reported Issues: 90 Prisms - Damaged, 10 Prisms – Lotion inside prism, and 10 Prisms – Image Quality Issues. Action Taken: Improve product reliability and production yields by updating product packaging, product design, and manufacturing process. Estimated savings $300K.

Wrote Production Procedures and trained personnel for successful outsource of LiveScan 3000 Product Family.

Updated Electro-Mechanical Manufacturing Drawings for successful outsource of SunRise 2000 Product Family.

Additional Work Experience:

Adaptec Inc., Milpitas, California (1995 - 1999) Senior Test Engineer / Failure Analysis Engineer

Unisys Corporation, UNIX Systems Division, San Jose, CA (1993 – 1995) Senior Test Engineer

Acer America, San Jose, CA (1990 – 1992) Senior Test Engineer / Product Engineer

Altos Computer Systems, San Jose, CA (1989 – 1990) Product Engineer

Education:

Bachelor of Science in Electronic Engineering Technology, DeVry University, Phoenix, AZ.

Professional Training:

Jun. 2022 Everything Test, RF Fundamentals Seminar, by Rohde & Schwarz, Torrance, CA

Jan. 2022 ISO 13485 Training, Abbott Labs, Sylmar, CA

Jan. 2022 CAPA Training, Abbott Labs, Sylmar, CA

Jan. 2017 AS9100 (Rev. D) Transition, Bureau Veritas, Ontario, CA

Jan. 2017 ISO9001:2015 Transition, Bureau Veritas, Ontario, CA

Jun. 2015 FMEA Training, Zodiac Aerospace, Cypress, CA

Apr. 2015 ISO 9001:2015 Auditor Transition Training, Zodiac Aerospace, Cypress, CA

Mar. 2014 ISO 9001:2008 Auditor Training, Value Added Quality Services, Irvine, CA

Mar. 2014 AS9100C Auditor Training, Value Added Quality Services, Irvine, CA

Sep. 2013 E15 107 FMEA from Six Sigma US

Nov. 2010 Business Writing for Results, Ontario, CA

Nov. 2006 Effective Communication, San Diego, CA

Jun. 2006 Motorola Six Sigma Training, Green Belt, Anaheim, CA

May 2004 Motorola Six Sigma Training, Yellow Belt, Anaheim, CA

May 2004 Motorola Six Sigma Training, White Belt, Anaheim, CA

Jul. 1997 ISO 9000 Internal Assessor Workshop, Peak Consulting Group, San Jose, CA

Apr. 1997 EMC/EMI Seminar, Compatible Electronics, San Jose, CA

Oct. 1996 EMC Design Seminar, Compatible Electronics, San Jose, CA

Feb. 1996 EMI/EMC Testing Seminar, Tektronix Inc., Santa Clara, CA

Sep. 1995 Visual Basic, UC Santa Cruz Extension, San Jose, CA

Jan. 1995 ISO 9000 Awareness Training, Unisys Corp., San Jose, CA

Jun. 1994 Front-line Management, Unisys Corp. San Jose, CA

Aug. 1994 C Programming, UC Berkeley Extension, San Jose, CA

Aug. 1993 Statistical Analysis, Unisys Corp. San Jose, CA

Dec. 1990 Advanced UNIX Programming, De Anza College, Cupertino, CA

Jun. 1990 UNIX Systems Admin. Cert., Altos Computers, San Jose, CA

Computer Experience:

Test Equipment: Logic Analyzer, Oscilloscope, SCSI Bus Analyzer, and ESD & EFT test equipment.

Computers: IBM Compatibles (PCI, EISA, ISA,), UNIX, Linux, and Mac Computers.

Computer Languages: Rational Visual Test, Visual Basic, VBA, VB-Scripts, Microsoft Access, C, HTML, SharePoint.

Software Applications: Microsoft (Word, Excel, PowerPoint Project, Outlook, Internet Explorer, Google Chrome, MS Edge, Visio, JIRA.

Software OS: Windows 11, Windows Server 2022, UNIX, Linux, DOS, MacOS Monterey, and Novell.

Hardware Test: MRB, CAPA, FMEA, PFMEA, PPAP, FAI, Tolerance Stack-up, GD&T, PCI, SCSI-3 (Ultra/Fast-SCSI, RAID, Fibre Channel, 1394, SSA, SPI), CardBus, PCMCIA, EISA, ISA ECL, TTL, CMOS, RoHS, WEEE, CE Mark, UL, CSA, ETL, Biometrics, and analog test knowledge.

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