Quality Engineer Assurance

Objective:

Obtain a Quality Engineer, Program Manager, Manufacturing Engineer, Test Engineer, NPI Engineer, Supplier Quality Engineer, DVT Engineer, Compliance Engineer, QA Engineer, Product Engineer, Reliability Engineer, or Business Analyst position where my skills and abilities can be utilized.

Summary of Qualifications:

Accomplished Quality Engineer with over 15 years of comprehensive experience across various roles in Quality Assurance and Engineering, including DVT/NPI Engineering, QA (Software/Hardware Test) Engineering, Failure Analysis, Reliability Engineering, Product Engineering, Business Analysis, Compliance Engineering, and Supplier Quality Engineering. Proficient in adhering to and implementing industry standards such as AS9100, ISO 9000, FDA 21 CFR Part 820, ISO 13485, ITAR, as well as other international regulatory frameworks.

Expert in Quality Control, Quality Management, and Quality Assurance principles, with a strong foundation in cGMP practices. Skilled in end-to-end Software and Hardware Validation Testing, encompassing Black Box, White Box, and Gray Box testing methods. Proficient in executing a wide range of testing types, including unit, acceptance, regression, performance, cybersecurity, usability, and smoke testing, to ensure product quality, reliability, and compliance.

Demonstrated Ability:

Root Cause & Risk Analysis: Expert in identifying and addressing root causes through Root Cause Analysis (RCA), Failure Mode and Effects Analysis (FMEA), including both Process (PFMEA) and Design (DFMEA) perspectives.

Metrics and KPIs: Adept at defining and monitoring critical performance indicators to drive continuous improvement and maintain high-quality standards across operations.

Production Quality Assurance: Proficient in supporting the Production Part Approval Process (PPAP), leading Advanced Product Quality Planning (APQP), and ensuring rigorous Process Validation (IQ, OQ, and PQ) to guarantee the precision, reliability, and durability of products. Experienced in conducting ISO and AS9100 Quality Management System (QMS) audits to ensure compliance and continuous improvement, fostering adherence to industry standards and enhancing overall operational excellence.

Continuous Process Improvement: Skilled in implementing Lean Manufacturing principles, including 5S, Kaizen, and continuous improvement initiatives, to optimize production flow and reduce cycle times. Experienced in applying Process Mapping, Value Stream Mapping, and work standardization to enhance efficiency across production lines.

Product Safety & Compliance: Conduct thorough reviews for product safety and hardware compliance, proactively identifying areas for improvement and mitigating risks.

Quality Control & Automation: Employ quality control systems like Statistical Process Control (SPC) and various control charts (e.g., Gantt, Pareto, Fishbone, Heat Maps) to monitor, analyze, and enhance production quality. Experienced in integrating automation and robotics to improve accuracy, speed, and safety in production processes.

Product Development & Technical Guidance: Partner with product development teams to provide quality insights, recommend process improvements, and support design through technical data analysis, manufacturing method evaluation, and tooling and equipment reviews.

Visual & Analytical Tools for Process Optimization: Proficient in creating and utilizing visual aids for process improvement, including flowcharts, value stream maps, and comparison charts, to enhance communication and drive data-driven decision-making in cross-functional teams.

Professional Experience:

Parker-Meggitt North Hollywood, California (11/2024 – 5/2025)

MRB Engineer / Supervisor, Aerospace

Responsibilities: MRB Engineer working in Aerospace. Frontline MRB Supervisor supporting manufacturing operations. Make decision on disposition of non-conforming material working with Quality Engineering, Suppliers, Engineering, and Program Management. Provide recommendations for process improvement.

Achievements:

Developed and implemented an “Easy Closure List” to expedite MRB resolutions and reduce backlog.

Collaborated with Purchasing and Suppliers to shorten turnaround times for supplier nonconformances.

Enhanced error reporting by integrating high-resolution imagery and investing in improved defect documentation equipment.

Eaton Inc., Camarillo, California (10/2023 – 10/2024)

Quality Engineer, Aerospace

Responsibilities: Conducted aerospace manufacturing quality assessments, reviewed work orders and customer purchase orders, and evaluated CAPA errors through comprehensive root cause investigations. Utilized advanced quality tools including 8D Reports, A3 Reports, fishbone diagrams, cause-and-effect diagrams, 5-Whys, Pareto charts, control charts, histograms, and checklists. Managed returned goods evaluations (RGAs), and ensured accuracy in FMEA, DFMEA, and PFMEA documentation. Conduct MRB reviews and assist with QMS ISO/AS9100 Audit responsibilities, focusing on process improvements. Conduct Reliability Testing/Analysis, EMI/EMC testing, DO160, HALT testing, and Root Cause Analysis.

Achievements:

Packaging Improvement: Improved packaging for 2,000 products by implementing an efficient system through 8D analysis, developing a detailed packaging guideline, issuing a Quality Alert, and conducting training for staff.

Coupling Nut Process Improvement: Led a quality initiative for 2,000 products by introducing a new deflashing procedure. Conducted thorough 8D analysis, updated inspection plans, developed new tooling, issued Quality Alerts, and provided targeted training to enhance product quality.

Walk Vascular, Irvine, California (12/2022 – 02/2023)

Quality Engineer, Medical Device Manufacturing

Responsibilities: Reviewed manufacturing work orders and monitored receiving inspection records, ensuring completeness of documentation. Evaluated CAPA errors and root cause investigations, applying various analytical tools including 8D Reports and Pareto charts. Assured compliance with FMEA processes and maintained MRB and assisted with QMS ISO responsibilities verifying cleanroom and sterilization requirements and ISO Post-Market Quality Compliance Audits.

Ring Inc., Hawthorne, California (06/2022 – 11/2022)

Quality Specialist

Responsibilities: Assessed customer returns, managed MRB reviews, and assisted engineering with prototype builds. Performed root cause analysis using advanced testing methods, including thermal testing, CT-Scans, X-Ray Scans, and SEM material analysis. Conducted rigorous product safety evaluations and extensive environmental testing for reliability.

Achievements:

Optimized Thermal Testing Process: Revamped the thermal testing process, resulting in improved report accuracy and reduced completion times.

Supplier Error Identification: Identified and resolved systemic supplier errors related to prototype solar cells during pre-production, leading to significant process improvements.

Material Analysis on Customer Returns: Conducted detailed analyses using SEM and EDXMA, providing critical insights into product failures.

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

Quality Specialist, Medical Device Manufacturing

Responsibilities: Led ISO 13485 and FDA 21 CFR Part 820 compliance initiatives across manufacturing operations. Conducted internal and supplier audits to identify systemic gaps and improve audit readiness. Analyzed post-market surveillance data to identify trends and drive risk-based corrective actions. Collaborated with cross-functional teams to implement CAPAs and support continuous improvement initiatives in line with MDSAP and EU MDR standards.

Achievements:

Supported CRM Abbott Japan audit by uncovering critical findings and delivering strategic quality analysis.

Strengthened supplier compliance and internal audit performance through data-driven process reviews.

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

Quality Engineer, LiveScan and AFIS Systems

Responsibilities: Managed quality control and assurance for biometric systems, including CAPA and SCAR activities, internal audits, and root cause investigations. Improved Takt time by redesigning production workstations and implemented a Kanban/binning system to boost throughput. Established site-wide ESD protocols across Production, RMA, NPI, and Stockroom, and launched a robust calibration program to ensure accuracy across all operational areas including Supply Chain.

Achievements:

Touchless Fingerprint Scanner Process Improvement: Addressed reliability issues in pre-production testing by revamping the assembly process and collaborating with suppliers, resulting in a product yield increase to over 90%.

Production Workstation Improvement: Enhanced Production Takt time by refining workstation design and functionality.

Kanban System Implementation: Streamlined Production Processes by implementing a Kanban/Binning System, allowing Production Assemblers to dedicate more time towards assembly increasing Production Output.

Established ESD Program: Established comprehensive measures to ensure ESD compliance across Production, RMA, NPI, and Stockroom.

Established Calibration Program: Developed systematic calibration procedures for accuracy in Production, Quality, RMA, NPI, and Supply Chain.

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

Quality Engineer, Aerospace Manufacturing

Responsibilities: Oversaw quality control, conducted audits, and implemented process improvements and training. Proficient in ISO 9001 and AS9100 practices. Created and maintained manufacturing process flowcharts and standard operating procedures (SOPs). Served as an auditor for QMS, APQP, ITAR/EAR, AS9100, ISO 9001, and ISO 14971, assessing compliance to SOPs. Supported and conducted internal product, process, and quality system audits. Managed root cause investigations using various methodologies, including A3 and 8D reports, Fishbone diagrams, and 5-Whys. Managed the MRB process, addressing failures and supplier SCARs.

Achievements:

Workstation Improvement: Reduced inspector errors by redesigning workstations using 5S methodology, streamlining processes, and providing targeted training. Achieved significant reductions in inspection errors and improved employee satisfaction.

Magnet Polarity Process Improvement: Developed and institutionalized new procedures for marking magnets, improving identification and testing of products in Production and Test to ensure proper product assembly.

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

Business Analyst / Quality Specialist, Aerospace Manufacturing

Responsibilities: Conducted quality control and audits for aerospace products, ensuring compliance with ISO 9001 and AS9100 standards. Managed CAPA/SCAR processes and supported internal audits and supplier evaluations. Engaged in root cause investigations and quality training initiatives.

Achievements:

Packaging Improvement: Identify and correct packaging deficiencies that led to damage during shipment. Implement Custom packaging solutions and revise production processes, leading to enhance customer satisfaction and reduced return rates.

Special Project for UL Certification Standards: Conduct comprehensive reviews of production and quality equipment, ensuring adherence to UL certification standards through upgrades and strategic stakeholder engagement.

Teledyne Battery Products, Redlands, California (10/2011 – 7/2013)

Senior Quality Engineer, Aerospace Manufacturing

Responsibilities: Led quality control and audits, managed CAPA processes, and ensured compliance with AS9100 standards. Engaged in supplier audits and root cause investigations to mitigate manufacturing risks.

Achievements:

Obtained AS9100D Certification: Led AS9100 Certification effort. Streamlined Production processes and enhanced compliance measures, leading to a successful company certification.

Developed Comprehensive Process Flowcharts: Created detailed flowcharts for the entire Production process in accordance with AS9100 requirements, improving clarity and efficiency.

Integrated Risk Management into Production Process: Implemented robust risk management strategies, aligning with AS9100 standards to proactively address potential Production and Quality concerns.

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

Senior Quality Assurance Engineer, LiveScan and AFIS Systems

Responsibilities: Managed quality control and assurance activities, including supplier audits and process improvement initiatives through Six Sigma methodologies. Oversaw document control processes for SOPs and conducted thorough root cause investigations using various quality analysis tools. Engaged in product testing and compliance verification across biometric product lines.

Achievements:

LiveScan 2000 Prism Improvement Project: Addressed significant customer-reported reliability issues, implementing design changes that resulted in cost avoidance savings of $300K. Enhanced product yield to over 90% through effective supplier collaboration and process redesign.

Spearheaded ROHS and WEEE Compliance Program: Ensured 100% compliance company-wide, enhancing product sustainability and regulatory adherence.

Streamlined Production Procedures: Developed and facilitated training programs that ensured successful outsourcing transitions and maintained high-quality standards.

Monitored and Reported KPIs based on CMMI guidelines, ensuring consistent quality improvements across all phases of the software development lifecycle.

Conducted CMMI Assessments for software development processes, identifying gaps and recommending improvements to enhance process maturity and ensure alignment with industry best practices.

Adaptec Inc., Milpitas, California (1/1995 – 7/1999) Senior Test Engineer / Failure Analysis Engineer

Responsibilities: Analyze Customer-returned products to the component level using (SCSI Analyzer, PCI Analyzer, Logic Analyzer, Digital Oscilloscopes, and DVM, BGA X-Ray). Recommend corrective actions and process modifications to improve ICT, Functional Testing, Quality Control, and Visual Inspection. Oversee QA for both hardware and software deliverables, including product verification through environmental, humidity, storage, MTBF, MTTR, and ESD testing. Conduct Electronics Reliability Testing, Reliability Analysis, EMI/EMC testing, DO160 certification, STRIFE/HALT testing, and Root Cause Analysis. Perform transportation and packaging tests, life testing, PCBA stress screening, and V&V activities. UL and CE Mark testing.

Education:

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

Professional Training

Date

Training

Date

Training

Jan. 2023

FMEA Training FMEA Specialist Certification (Accredited), Instructors: Advanced Innovation Group Pro Excellence (AIGPE)

Jun. 2022

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

Jan. 2022

ISO 13485 Training, Abbott Labs, Sylmar, CA

Mar. 2014

AS9100C Auditor Training, Value Added Quality Services, Irvine, CA

Jan. 2022

CAPA Training, Abbott Labs, Sylmar, CA

Sep. 2013

E15 107 FMEA from Six Sigma US

Jan. 2017

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

Nov. 2010

Business Writing for Results, Ontario, CA

Jan. 2017

ISO9001:2015 Transition, Bureau Veritas, Ontario, CA

Nov. 2006

Effective Communication, San Diego, CA

Jun. 2015

FMEA Training, Zodiac Aerospace, Cypress, CA

Jun. 2006

Motorola Six Sigma Training, Green Belt, Anaheim, CA

Apr. 2015

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

May 2004

Motorola Six Sigma Training, Yellow Belt, Anaheim, CA

Mar. 2014

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

May 2004

Motorola Six Sigma Training, White Belt, Anaheim, CA

Sep. 2013

AS9100C Auditor Training, Value Added Quality Services, Irvine, CA

Jul. 1997

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

Nov. 2010

AS9100C Auditor Training, Value Added Quality Services, Irvine, CA

Jan. 1995

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

Nov. 2006

AS9100C Auditor Training, Value Added Quality Services, Irvine, CA

Jun. 1994

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

Aug. 1993

Statistical Analysis, Unisys Corp. San Jose, CA

Aug. 1994

C Programming, UC Berkeley Extension, San Jose, CA

Dec. 1990

Advanced UNIX Programming, De Anza College, Cupertino, CA

Jun. 1990

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

Experience:

Test Equipment: CT-Scan, X-Ray, Thermal Imaging, Logic Analyzer, Oscilloscope, SCSI Bus Analyzer, EMC/EMI Testing, and ESD & EFT test equipment.

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

Computer Languages: C-Shell, Bourne Shell, Python, PyTest, SQL, Visual Basic, VBA, Visual Test, VB-Scripts, Microsoft Access, C++, C, RESTful, WebServices, HTML, MySQL, Java, Tableau, and SharePoint.

Software Applications: Microsoft (Word, Excel, PowerPoint, Outlook, and MS Project), Internet Explorer, Google Chrome, Microsoft Edge, Firefox, Visio, SAP, Windchill, JIRA, Z2Data's Part Risk Manager, Minitab, and QI Macros.

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

Hardware Test: Test Verification: PCI 64 bits /133 MHz 1 Gbps, PCI 32 bits /33 MHz 1 MBps SCSI-3 (Ultra/Fast-SCSI, RAID, Fibre Channel, 1394, SSA, SPI), CardBus, PCMCIA, USB 3.0, USB 2.0, EISA, ISA ECL, TTL, CMOS, REACH, RoHS, WEEE, CE Mark, UL, CSA, ETL, Biometrics, and analog test knowledge. Hardware Test: CT-Scan, X-Ray, Scanning Electron Microscope (SEM) Material Analysis, Energy Dispersive X-ray Microanalysis (EDXMA), Thermal Imaging, and Product Verification; including, Environmental Testing, Thermal Evaluation Testing, Humidity Testing, STRIFE/HALT Testing, and Storage Testing. Failure Analysis: Analyze Customer Returns (Root Cause Analysis).

Hardware Compliance: UL, CSA, ETL, CE Mark, ROHS, REACH, WEEE Compliance Verification, WEEE Conflict Minerals, Proposition 65, SCIP Database, Battery, and Packaging directives. EMI/EMC, RTCA DO-160, STRIFE/HALT Testing, Root Cause Analysis.

Quality Improvement: APQP, Risk-Based Thinking Analysis, Root Cause Analysis, A3 Reports, 8D Reports, Proficient in Problem-Solving skills utilizing quality tools and concepts (Fishbone Diagrams, Cause-and-Effect Diagrams, 5-Whys, Pareto Analysis Report, Control Charts, Histograms, Process Capability (Cp/Cpk & Pp/Ppk Analysis), Measurement Statistical Analysis (MSA), Checklists, Defective Parts Per Million (DPPM), Defects Per Million Opportunities (DPMO), Defects Per Unit (DPU), Parts Per Million Defective (PPM), First Pass Yield (FPY), and Rolled Throughput Yield (RTY)), Cost of Poor Quality (COPQ) Analysis, and SPC-Statistical Process Control Reports, Measurement Gage Analysis.

Product Safety: Hot-to-Touch, Fire Damage, Water Damage, Water Egress, Water Ingress, Metal Fatigue, Product Wear, Sweat, Weather Exposure Damage, and Rust. Stringent testing to ensure that products work properly in hot, cold, and humid climates; verification tests should account for the different environmental, vibration, and mechanical-force stress electrical and electronic devices endure during usage and storage. Manufacturers must ensure that their devices will perform efficiently, whether in Singapore, South Africa, or Sweden.

PCB and Cables: IPC-600, IPC- 610, IPC-620 Knowledge.

Quality Control: MRB, CAPA, SCAR, Equipment Calibration, Employee Training to Procedures, Processes, & QMS Audit Preparation, Review & Revise Procedures (SOPs) including Policies, Procedures, Flowcharts, and Work Instructions. Manage Quality Management System (QMS) and Audit Program, Supply Chain Audit Responsibilities.

Quality Metrics: KPI Reports, SPC-Statistical Process Control Reports, Cost of Poor Quality (CPQ), DPPM Report, Pareto Analysis Report, Cleanroom Monitoring Reports, and Supplier Scorecards.

Design Verification: Design Validation Testing (DVT), Power Electronic Analysis Testing, Reliability Testing & Analysis, EMI/EMC Validation & Testing, DO160 Testing, STRIFE/HALT Testing and Analysis, Root Cause Analysis, New Product Introduction (NPI), BOM / DWG Validation, Production Part Approval Process (PPAP) and Validation, DOE-Screening Experiments, FMEA, DFMEA, PFMEA, FMEA Traditional RPN, Process Validation (e.g., Process Installation Qualification (IQ), Process Operational Qualification (OQ), and Process Performance Qualification (PQ)), Supplier Verification, Verification (REACH, RoHS, WEEE, CE Mark, UL, CSA, ETL), cGMP Verification, GMP, Conflict Minerals, Proposition 65, SCIP Database, Battery Packaging & Labeling Requirements, and Packaging Verification.

Software Test: Quality Assurance Software Test: Black Box, White Box, and UAT testing (Test Plans and Test Reports); Software Automation Testing.

Lean Six Sigma: Proficient Problem-Solving Skills utilizing Six Sigma Tools (Fishbone Diagrams, Cause-and-Effect Diagrams, 5-Whys, Pareto Charts, Control Charts, Histograms, Process Capability, MSA, Cp/Cpk, Pp/Ppk, Checklists, DPPM, and First Pass Yield, 5S's/6S's, Kanban, Gemba Walks, Kaizen, Value Stream Mapping, and Mistake-Proofing / Poka Yoke). Implementation/Verification of Corrective Actions; Institutionalizing Corrective Actions through ECR/ECN Process. Software: Minitab, and QI Macros.

Quality Audits: Internal Auditing, External Auditing, Regulatory Audits (ISO 9001:2015, AS9100D, ISO 13485, 21 CFR 820 & ISO 14971), Corporate Audits, and Supplier Audits & Scorecards. Compliance Assessment to SOPs (GAP Analysis), Post-Market Quality Compliance, APQP-Advanced Product Quality Planning, QMS Planning. Support and conduct Internal Product, Process, and CMMI, Quality System audits.

Medical Device Regs: ISO 13485, ISO 14971:2019, IEC 60601, CFR Part 820, EU MDR, MDSAP, and IMDRF.

Aerospace Regs: AS9100 and 14971:2019, International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR), Federal Acquisition Regulations (FAR), National Institute of Standards and Technology (NIST) Cybersecurity Framework, EASA CS (European Aviation Safety Agency Certification Specifications), EAR (Export Administration Regulations), and Environmental Protection Agency (EPA) Regulations. ISO 14001 (Resource Efficiency, Waste Management, and Environmental Impact Reduction), ISO/IEC 27001 (protection of sensitive information and data security), ISO/IEC 17025 (Testing and Calibration), MIL-STD-810 (Environmental Testing), IEC 60068 area IEC 60068-2-14 (Vibration) and IEC 60068-2-78 (Damp Heat), SAE ARP5412 (Design and Testing Methods for Aircraft Systems to Mitigate the Effects of Lightning), FAA AC 20-136B (Testing Methods for Lightning Protection), and RTCA DO-160 (Environmental Conditions and Test Procedures for Airborne Equipment).

Quality Inspection: First Article Inspection (FAI) AS9102, Certificate Verification, Hardware Inspection, Sample Size Planning & Verification, DWG Certificate & Packaging Verification. Geometric Dimensioning and Tolerancing (GD&T), Measurement System Analysis (MSA), and Gage R&R.

Languages: English (Proficient) and Spanish (Basic).

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