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Quality Engineer Resume Profile

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Summary

Seeking Position as Quality Investigator CAPA / Quality Engineer / Quality Auditor / Technical writer / Proposal Contract writer / Product Review Engineer / Manufacturing Process Engineer / Process Controls Engineer / NPI Engineer / Research Analyst.

PROFESSIONAL SUMMARY:

  • Secret Clearance Secret Eligibility-Previously held .
  • Over Twenty years experience with Aerospace, Automotive, Medical Device, Electro-Mechanical, Opto-Electronics, Defense Commercial Product.
  • Worked as Project Quality Manufacturing Engineer on New Product Development General Dynamics-Crusader Tank Built 2 Prototype units , new product line development, Design reviews, Controls and qualification for automotive sensor VDO Control Systems and product line transfer and new start-up in Monterrey, Mexico The Hershey Chocolate Co .
  • Worked as Project Engineer ISO 9000 Quality Systems Certificate Registration on new plant Lucent Technology , Appliance Division GE , Helicopter Manufacturer Sikorsky Aircraft to achieve AS 9100 Quality Systems Certificate.
  • Worked as Senior Quality Engineer Textron Aero Structures B1-B wing first article conformity inspection FACI for production certification. Liaison with Customer / Government Representative.
  • Performed Supplier Performance Assessment on Cameron Compression Systems Quality Systems, Risk Management, Product and Process Controls, and Capability elements evaluation. Prepared Report: Quality Audit findings by Critical, Major, Minor and Opportunity for Improvement Categories, Assessment output, Risk Output Table, Site Rating, Conclusions, Recommendations and Executive Summary.
  • Reviewed requirements for suppliers to procure products. VDO Control Systems / Lucent Technologies / General Dynamics Land Systems / General Electric / United Defense Corp BAE Systems / Sikorsky Aircraft Corp / UTL Corporation / SKF Aerospace / Gulfstream Aerospace Wrote/Updated procedures to ensure the Supplier Quality management system is compliant. Prepared, documented and computerized supplier requirements to input onto purchase orders.
  • Participated in the Supplier Selection Process. Performed Supplier audits to determine compliance with safety, emission, control characteristics, contractual requirements, process control capabilities and quality standards.
  • Defined and developed Supplier Quality Program plans, inspection, verification, qualification, statistical process control methods, practical solutions to a wide range of problems in quality systems, materials and electro - mechanical products. Worked with suppliers and program management to identify root cause and corrective actions.
  • Performed Contract reviews for request for proposal RFP / request for quotation RFQ . Performed quality function deployment QFD , feasibility and company's capability analysis to fulfill contractual requirements.
  • Performed Pre Contract evaluation, ISO/QS 9000/AS 9100 preparation and Post contract and Monthly Quality Audits. Evaluated Standards and Contractual requirements. Audited Systems, procedures, policies, directives and work instructions for Plant wide and Subcontractor's compliance. Prepared Quality Deficiency reports and Corrective Action plans.
  • Planned, organized, controlled and integrated Project activities and expenditures. Developed QA systems, Procedures, Instructions and Audit Checklists. Prepared and Implemented Quality Training, Statistical Quality Process controls plans.
  • Performed Product Design Reviews / Change Control / Modification Analysis and FACI per AS 9102 . Supported new product developments / Production / scheduling / engineering design and tests problems resolution. Ensured completed product is manufactured per the approved quality systems requirements and is certified as compliant to type design requirements.
  • Assessed, planned, and accomplished assigned tasks on schedule. Managed all levels of technical documentation, from concept to final acceptance Production Part Approval Process PPAP documentation, New Product Introduction NPI and Prototype Development Documentation . Technical experience encompasses electro-mechanical, avionics and software.
  • Provided Quality System Engineering, Advanced Product Quality Planning APQP , New Product Development NPI Design and Prototype evaluation, First Article Conformity Inspection FACI , Production Part Approval Process PPAP documentation, Quality Audits, Product Review, Process Product Verification, Process Improvement, Define, Measure, Analyze, Improve and Control DMAIC, Consulting, Assessment and Preparation support to meet ISO/QS 9000/AS 9100 registration requirements.
  • Applied standard quality tools such as FMEA Failure Modes Effect Analysis , SPC Statistical Process Control , Root Cause Analysis, DPAR Design, Process and Assembly Review , PPAP Production Parts Approval Process , Control Plans, Pareto analysis, Gage Repeatability and Reproducibility GR R and Geometric Dimension and Tolerance GD T .
  • Performed Root cause analysis RCCA 5 WHY, Fishbone / Cause and effect Diagram-process classification-dispersion analysis-cause enumeration types and Corrective actions preventive actions CAPA , Chaired Material Review Board MRB and conducted weekly MRB meetings for disposition of non conforming materials NCM .
  • Evaluated and organized work stations using 5S techniques. Analyzed operations and implemented 7 waste elimination methods. Developed and implemented Poka-Yoke systems and fixturing. Participated in Kaizen events. Applied various six sigma tools.
  • Audited system for Retention, storage, retrieval and destruction of records. Designed coding, reporting systems and filing methods.
  • Prepared Procurement Specification / Test requirements / Source Inspection / Vendor Control Requirements / First Article conformity Inspection FACI / Audits Evaluation Documentation. Performed incoming / In-process/ Final Inspection. Wrote Inspection / Test methods, Sampling Plans and Procedures. Performed QA Planning, Qualification Testing and Change Control Reviews and Audits. Recommended Corrective Action. Performed feasibility and capability evaluations and analysis.
  • Wrote, updated and edited Operation/User Maintenance Manuals, Service Bulletins, Task Cards, Technical / Specification writing, Modification Procedures, Illustrated Parts Lists, Component Maintenance Manuals and Fault Isolation Manuals. Developed Training Materials. Wrote specification documents for outsource vendor services. Provided administrative and implementation support.

SPECIFICATIONS:-

  • MIL-STD, AIAG, ISO, ANSI, ASME, ASTM, CFR for Production Certificates , NASA specifications, Government codes and FAR, OSHA environmental regulations pertaining to Quality, Reliability, Maintainability, Inspection and Calibration systems, MRB, Corrective Action systems CAPA and NC Systems, Military Sampling Plans, Purchase Materials QA requirements, Drawings, Specifications, Non - Destructive Testing, Manufacturing, Systems, Configuration and Engineering Management and Electrostatic Discharge ESD .
  • MIL-I-45208A, MIL-Q-9858A, MIL-STD-105D, MIL-HDBK-H53A, MIL-C-45662, MIL-STD-1235A, MIL-STD-1520C, MIL-STD-1535A, DOD-STD-480A, MIL-STD-481A, NHB-5300.4 B , NHB-5300.4 C , FAR 14 CFR 21, ASME Y14.5 GD T , DOD-D-1000/DOD-STD-100, MIL-HDBK-728, ISO/QS9000, AS9100, TS16949, ISO14001, ISO13485, FDA 21CFR- 11 820 ,Gamp5, API Q1, Q7A cGMP -API.

EQUIPMENTS:

  • Have used the following Dimensional Measuring Tools, Precision measuring Instruments, Coordinate Measuring Machine CMM , Optical Comparator, Surface texture / finish checker and Non-Destructive testing NDT equipments.
  • Surface Plate, Master Gages, Gage Blocks, Parallel Bars, Angle Plates, V-Blocks, Sine-Bars, Verniers Calipers, Micrometers, Indicators, Depth Gages, Drop Test Indicators, Holders Accessories, Height Gages, Inside Diameter Measurement Gages, Sizing Gages, Snap Gages, Radius gages, Length, Diameter Distance Measuring Tools, Squares, Combination Squares Protractor, Tapped Hole Location Gages, Thread Gages, Thickness Feeler Gages.
  • Profilometer Surface Finish , Rockwell Bernell tester Hardness , Non-Destructive Testing NDT equipments, Magnetic-Particle-testing Magnaflux machine, Flourcent Penetrants, Ultrasonic and Radiographic X-ray testing equipment.

COMPANY / JOB TITLE / JOB FUNCTIONS DETAILS / ACCOMPLISHMENTS

Confidential

Sr. Process Quality Manufacturing Engineer/Auditor Automotive steel frames, components, metal stampings and welding operations

  • Quality Improvement Process TZ5 Product Line - HONDA Acura MDX : Prepared Manufacturing, Quality Inspection / Testing Documentation and Illustration Template for process improvements using pictures created of manufactured assemblies on production floor with pictures created from ENOVIA 6 DMU and CATIA 5 Softwares to validate Manufactured Product confirm to as Designed Configuration . Prepared Graphic Operations sheets and Red Sensor Parts Verification set up sheets for product assembly line to Ensure Parts set up in Jig fixtures properly and all Sensors on fixture function correctly, prior to start of production run. Evaluated current manufacturing processes and identified quality issues. Defined and developed In Process and Final Quality Inspection System based on verification of Catia 5 Design Characteristics to Current Manufactured Product Characteristics.
  • Cameron Compression Systems, OKC, OK 73129 SQA Services, Rolling Hills Estates

Confidential

Sr. Quality Engineer - Lead Auditor Support

Supplier Quality System Assessment - Performed Supplier Performance Assessment, Risk Management, Product and Process Controls, and Capability evaluation. Presented Quality Audit findings by Critical, Major, Minor and Opportunity for Improvement Categories. Prepared reports on Assessment output, Risk Output Table, Site Rating, Conclusions, Recommendations and Executive Summary.

Confidential

Quality Engineer FAI Documentation

First Article Conformity Inspection Document Preparation per AS9102 using Solumina G4.

Result: Improved logistic support to FAI operation on floor.

Confidential

Quality Investigator / Auditor / Technical Writer

  • Quality Audits / Root Cause Investigation Analysis RCCA / Corrective Action Preventive Action CAPA / Non Conforming Materials NCM / Customer Corrective Action Reports CARs - Performed Root cause investigation and analysis. Applied systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Corrective Action Preventive Action CAPA and Non-Conformance NC issues. Provided support during audits/inspections relating to the CAPA and NC system. Ensured effective CAPA and NC data analysis SPC Methods / Pareto Charts, etc , investigation, and evaluated their trending. Resolved and followed up customer complaints in a timely manner. Performed Monthly Quality Audits. Prepared Technical Reports and report of the Corrective Action CARs , Quality Audits, CAPA and NC process. Issued Internal CARs and non compliance notices to line managers and External CARs to suppliers. Monitored suppliers key manufacturing processes and quality management system for improvement.
  • Result: Helped reduce open CARs. Identified manufacturing floor issues and notified Line managers for resolution.

Confidential

Project Quality Mfg. Engineer / Technical Writer

  • New Product Line Start up Project Engineer / CAPA / Six Sigma / Technical Writing / Technical Support / Training Materials and Videos Preparation - Global supply chain - Plant transfer to MEXICO. Resolved new line startup quality issues. Set up program and procedures to perform required Corrective Actions and preventive measures CAPA . Prepared Quality systems, CAPA, technical procedures, work instructions, training materials, Training videos and illustrations.
  • Result: Pre planned for smooth startup of new product line and Technical Support at Monterrey, Mexico.

Confidential

Proposal Writer - Department Of Defense DOD

  • Proposal Writing / Quotation Preparation /Feasibility Analysis / In House vs. Out Source Vendor Documentation
  • Wrote quality proposal plans and prepared quotations. Performed Feasibility Studies, Risk Analysis, scope of work, In house VS out source, Cost and Manpower Analysis. Prepared specification documents for outsource vendor services.
  • Result: Prepared and submitted proposal for Department Of Defense DOD contract within due date.

Confidential

Research Analyst

  • Technical Research Analysis Testing Wrote procedures and tested computerized investment strategies. Evaluated opportunities and based on expected investment return with associated risk.
  • Result: Investment growth over 9 annually.

Confidential

Document Control Engineer

  • Built vs. Designed Configuration Process Verification / CAPA Investigation / Procedures vs. Contract Requirements Analysis
  • Reviewed Design History File documentation and verified built end product confirms to designed configuration. Reviewed product performance data and categorized to identify trends. Performed process and equipment validations Conducted CAPA investigations to determine the root / probable causes. Coordinated configuration control / deliverables / documentation support. Prepared configuration documentations to comply with FDA regulations. Reviewed Medical Device records procedure VS contractual requirements.
  • Result: Timely accurate records on Build Variance Detection, Enhance Ability to rebuild and Change Control Management for each Configuration Item.

Confidential

Process Control Engineer / Risk Analyst

  • Risk Analysis and Process Control Engineering. Performed Risk Analysis Potential Failure Mode and Effects Analysis PFMEA . Identified Quality improvements and overall process optimization. Calculated the Risk Priority Number RPN based on Severity, Occurrence, and Detection along with recommended actions. Ensured robust process controls are in place to prevent nonconformities. Monitored and evaluated key manufacturing processes and quality management system for improvement opportunities
  • Result: Identified methods to eliminate or reduce chances of potential process failure to improve performance.

Confidential

New Product Development Quality Engineer NPI QE

  • New Product Development and Qualification / Six Sigma / PPAP / APQP / MSA / PFMEA / 8D CAPA / NCM / QFD / Technical Procedures writing / Supplier Quality Audits and control Reviewed contracts, designs, drawings and item specifications. Performed quality function deployment QFD , feasibility and capability analysis, Pareto analysis, GR R and GD T. Developed Systems Technical Procedures for new contract. Performed quality planning, control, and improvement support to product development teams, manufacturing teams, supply management, manufacturing and distribution organizations to meet the customers' quality expectations. Prepared and Implemented product quality requirements, SPC, Sampling inspection plans and Training Materials on new product line. Performed DPAR Prepared PPAP documentation Quality Control Plans, Process Flow diagrams, Failure Mode Effects Analysis, Inspection Reports, Part Submission Warrant-PSW . Reviewed process capability on key tool/processes. Performed Advanced Product Quality Planning APQP , Machine /Line Qualification, Measurement Systems Analysis MSA , Problem solving, 8D Closed-Loop Corrective Actions Preventive Actions CAPA and Potential Failure Mode and Effects Analysis PFMEA . Provided project direction, coaching, and mentoring for Quality technical team personnel. Tracked RCCA and Evaluated non conformances created. Prepared reports on the product line issues, CAPA and Non Conformance NC process status. Assisted suppliers with APQP activities to ensure production readiness for New Product Introduction NPI . Presented findings and recommendations to upper management.
  • Result: Approval for delivery of Sensor product with Renault Automotive French Auto-Manufacturer .

Confidential

Project Engineer ISO 9000 Registration / Systems Procedure Manual Writer

  • Contract Review / QFD / Technical Writing / Trend Analysis / Audit Preparation for ISO 9001 Quality Systems Certification Planned, organized, controlled and integrated ISO 9001 registration plans strategy. Evaluated and supported manufacturing activities per ISO 9001 and contractual requirements. Performed quality systems, procedures, documentation, test data audit for companywide and subcontractor's compliance. Prepared trend analysis of audit results to identify quality system deficiencies. Prepared documents, critical analysis, summaries of industry requirements. Created flow charts / mapped quality processes and methodologies to improve the efficiency and accuracy of processes. Identified deficiencies for corrective actions and quality improvements. Updated Statistical Process Control SPC , Quality systems and procedures manual. Prepared Illustration and wrote Training Materials. Assisted in quality program and ESD precautions implementation and training. Worked with the suppliers to ensure robust process controls are in place.
  • Result: Helped achieve ISO 9001 Quality Systems Certificate Registration.

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