SUMMARY

• Well organized, innovative Quality Management professional with broad experience with a variety of manufacturing special processes and systems within the aerospace, automotive, medical/ pharmaceutical packaging and commercial manufacturing industries
• Skills and quality activities includes FAA approved part 145 repair station, auditing, supplier qualification, NCMR product management, CAPA management, statistical process control (SPC), design of experiments (DOE), quality engineering, quality planning, APQP FMEA, PPAP, product release, NADCAP management, receiving inspection, development and presentation of training materials and complete direction of the quality function
• Excellent and strong communication skills, systems and planning capabilities
• Self motivated with a passion for QA and proven problem solving ability
• Implemented ISO - 9001:2008/ AS9100:2009 quality management systems and Certified Lead Auditor in ISO/AS9100
• Management of Rejection Tags and Corrective Actions
• Management for ISO-13485 medical device and US FDA Title 21 CFR quality management systems
• Experienced in American E-Liquid Manufacturing Standards (AEMSA)
• Computer Skills: MS-Word / Excel / PowerPoint / Project, XP / Vista / 7, QuickBooks, Pro2009, JobBoss, UniPoint, Vantage, Team Center, SAP, Mini-Tab, Visio, Net-Inspect.com, IAQG Oasis.org, and various other proprietary databases
• ITAR certified US Citizen

PROFESSIONAL EXPERIENCE

Confidential, Riverside CA

Sr. Quality Engineer

Responsibilities:

• Provide support to the Supply Chain Management organization relative to the collection and analysis
• f supplier quality data.
• Provide expertise in Quality Assurance and process improvement tools and methods.
• Execute organization initiates in the development, implementation and improvement of the AS9100 / ISO9001 Quality Management system throughout the operation.
• Develop, implement and auditing of inspection and test plans, standards and acceptance criteria, and procedures / work instructions.
• Facilitate the investigation and elimination of causes of quality problems and corrective actions follow-up.
• Develop and analyze statistical data and product / process performance and recommend and implement improvements in targeted areas of the organization.
• Provide support in development and evaluation of process capability, process control plans, analysis of out-of-control conditions, and process audits with the objective of improving the process performance and capability.
• Participate in all aspects of product development and launch activities through the organization to
• help ensure quality goals are met on new nacelle development programs.
• Responsible for several components of a project and complex component of a larger project.Improvements
• Reduction of Quality Notifications by implementation of visual aids ratifying recurring root causes.
• Improved FPY efficiency 60% by leading manufacturing cells through weekly Quality Notification root cause training emphasizing cause and effect and remedying countermeasures.

Confidential, LLC, Corona, CA

Quality Assurance Director, (Consultant)

Responsibilities:

• Developed, oversee, and administer quality assurance program and QA management systems
• Oversee maintenance and reporting of product conformance to engineering and customer specifications
• Review the production process for conformance to quality standards directs resolution to quality problems
• Reports/tracks any significant deviations from quality standards and recommends corrective action as necessary to management
• Participates in new product development to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
• Visits material and component suppliers to review quality concerns and issues in an effort to minimize inspection requirements at the corporation's business unit
• Drives quality and continuous improvement throughout the organization
• Develops programs to encourage each employee to perform quality control as a part of their daily operation
• Established and presented regular training sessions for inspection and manufacturing employees on quality issues
• Supplies corrective action to escalated end user and distributor issues and concerns regarding product quality
• Trains and coaches employees within the Quality department, and works closely with Technical Support Specialists to track product quality issues
• Established strategic plans and sets policies on quality assurance Improvements
• Revised and created new and effective Quality Policy, Quality Metrics, and Safety Policy to best support organization
• Improved FPY efficiency, created new standard operation procedures and work instructions, implemented change control board process, and developed new standardized training matrix records

Confidential, Santa Ana, CA

Sr. Quality Engineer, (AEROTEK Contract)

Responsibilities:

• Interpret engineering drawings to confer withmanagement or engineering staff to determine quality and reliability standards
• Recommend modifications to existing quality or production standards to achieve optimum quality within limits of equipment capability
• Evaluate data and write reports to validate or indicate deviations from existing standards
• Prepare graphs or charts of data or enter data into computer for analysis.
• Record test data, applying statistical quality control procedures
• Compile and evaluate statistical data to determine and maintain quality and reliability of products.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, or anticipated delays
• Confirm that all standard operating procedures are being completed. Confirm that all operations comply with all state and federal laws for safety and labor compliance
• Perform internal audits per ISO-9001:2008/AS9100 C guidelines
• Support internal CAR/PAR system through daily reporting for Root Cause, Immediate and Long Term Corrective Action, and Effectiveness Validation
• Perform other related duties as assigned or related to position Improvements
• Identified opportunities for new and refresher certification training for production employees in application for bonding adhesives and primers

Confidential, Perris, CA

Quality Assurance Director, (Consultant)

Responsibilities:

• Directed Quality Assurance department activities and ensured quality standards intended for the company where maintained (ISO 9001:2008, AS91000 C and NADCAP for Heat Treat)
• Maintained surveillance over all company activities that had a direct or indirect effect on the quality of products produced and sold by the company
• Project Manager to the upgrade / revision of quality system programs and documentation from the ISO 9001-2008/AS9100 Rev. B quality standard revision to the ISO 9001-2008/AS9100 Rev. C quality standard requirements
• Performed internal/external quality system compliance audits according to the ISO 9001, AS9100 and AS9101 aerospace industry quality standard requirements
• Provided 3rd Party Level II Controlled - Shipping Inspection services and documentation to aerospace, automotive, defense and military sector manufacturing companies according to customer specifications and industry standard requirements
• Solid experience in training and managing multiple inspection personnel simultaneously and managing multiple inspection assignments
• Established professional rapport within all levels of internal and customer production personnel as well as developing and managing inspection documentation, collecting and managing data, and statistical performance analysis Improvements
• Provided direction to a team of 12 Quality Assurance team members by establishing clear expectations, metrics, and mentoring
• Improved FPY efficiency, implemented operating procedures, work instructions, and developed Lean manufacturing processes

Confidential, Cypress, CA

Quality Assurance Manager

Responsibilities:

• Directly responsible for development, updating, and control of the ISO-9001:2008, AS9100 Rev. C, ISO-13485 and US FDA CFR Title 21 standards Quality Management System
• Ensured that new and revised customer and regulatory quality requirements are incorporated within the system as required and followed
• Responsible for the proper communication of the Quality Management System changes, including but not limited to training personnel on new or revised requirements or systems
• Directed the activities of Quality Engineers, Quality Supervisor, and the Quality Inspection Group. Provided technical expertise and guidance regarding daily activities and quality initiatives
• Worked with top and middle level management to initiate actions necessary to insure that customer, statutory and regulatory requirements are fulfilled
• Responsible for the organization and supervision of Quality, Engineering, Inspection and Calibration Laboratory staff
• Monitored competency and organization of the personnel whose activities affect product quality with in quality organization
• Ensured the quality, clarity, accuracy, and control of Quality, Manufacturing and Engineering documents which govern the products being produced
• Ensured that procedures used in the purchasing of materials, supplies, and services related to product quality comply with company and contractual requirements
• Maintained the metrics and managed supplier and vendor performance as established in the Quality Management System and best practices
• Responsible for coordinating and facilitating resolution of quality concerns and issues. Key focal and site leader of the management team during a quality crisis and deployed quality crisis tools to manage the incident
• Directed the performing internal audits and execution to company audit plans
• Assisted in performing supplier base audits, surveillance and qualifications
• Maintained historical data of Corrective Actions for internal and external issues
• Identified cross-training opportunities between lab, inspection, NDT and gage issuance personnel
• Implemented training and monitored compliance following training
• Oversaw the calibration, maintenance and repairs of laboratory equipment in a manner to have minimum impact on operations
• Evaluated and recommended laboratory equipment upgrades and purchases
• Responded to customer inquiries in regard to product quality inquiries
• Lead root cause analysis and corrective action on product quality issues
• Implemented corporate wide Quality initiatives and provided monthly quality metrics to support company group reporting
• Shared and teamed best practices with and from the other Hyatt Diecast & Engineering Corporation facilities Improvements
• Established new MRB streamlined process yielding 60% improvement turnaround
• Upgraded manufacturing processes, systems and capabilities adding $1 mil in efficiency and productivity gains

Confidential, Huntington Beach, CA

Quality Assurance Manager, (Consultant)

Responsibilities:

• Ensured that overall quality of final product meets or exceeds customer and federal regulations for Aerospace, Medical Device, and Commercial Industries
• Responsible for all aspects of Quality Control as it relates to the ISO-9001:2008/AS9100 Rev. C, ISO-13485 and US FDA CFR Title 21 quality management systems and manufactured products
• Manage development, planning, implementation, release, and maintenance of Quality Control methods, procedures, processes, and operations for new and existing products
• Ensured that finished / intermediate products continue to conform to specifications. Formulated / recommended quality policies, quality objectives, procedures and programs
• Developed performance assessment effectiveness program to analyze statistical data and product specifications to determine preset standards performance and establish continuous improvement opportunities based upon real-time performance metrics
• Managed Change Control, Customer Complaints, RMAs, CAPAs, NCRs, Internal Audits, 3rd Part Audits, Supplier Performance, Customer Satisfaction, and Supervision of Quality Control Inspection Team Improvements
• Implemented an aggressive Gross Profit improvement corrective action plan to turn negative margin contracts profitable by instituting LEAN principles, new CNC programming, and tooling improvements

Confidential, Garden Grove, CA

Quality Assurance Manager

Responsibilities:

• Maintained the Quality System ISO-9001:2008/AS9100 Rev: C ensuring compliance to ISO/AS standards, regulatory and customer requirements
• Drove effectiveness of Quality Policy by promoting continuous quality improvements, i.e., process evaluations and improvements resulting achievement of business objectives
• Responsible for maintaining the Quality System; AS 9100/ISO 9001 Certification
• Ensured Integrity of Document and Data Control; and Specifications and Standards (internal and external) Libraries throughout the organization
• Management/Review/Correction of customer complaints
• Trend analysis: RMA’s, warranty repairs, customer complaints, inspection, receiving inspection, vendor quality
• Managed the CAPA system
• Supervised Inspection team, including Calibration/Metrology Coordinator(s)
• Training and Certification programs Improvements
• Achieved an 18% productivity improvement while meeting a 98% FPY rating

Confidential, Santa Ana, CA

Quality Assurance Manager

Responsibilities:

• Managed ISO-9001:2008/AS9100-C quality management system for Aerospace Metal Manufacturing Job shop
• Provided leadership and direction to 9 Quality Control team members over multiple shifts
• Managed internal & supplier qualification audits (lead role), NCR, CAPA, MRB reviews & dispositions
• Maintained Quality Metrics; Quality, OTD, Cost, and Safety
• Participated in contract reviews (NPR) to ensure Customer, Regulatory and Statutory requirements correctly interpreted, flow-down, and performed
• Maintained customer supplier quality portals (Alenia, Boeing, Bombardier, Spirit Aerospace, Lockheed Martin, Northrop Grumman, Raytheon Missiles Systems and Triumph) as well as Industry (Net Inspect, Oasis)
• Oversaw first-article CMM inspections and FAI including Deltas, Development/ implementation of Quality process control plans/internal procedures/work instructions, Calibration system, Planning documentation through Vantage ERP management system, Organization Management Representative during 3rd party audits Improvements
• Facilitated implementation of robust AS9100 quality system to meet customer requirements, taking First Pass Yields to over 95% from low 80’s
• Turned around negative customer service perceptions by improving delivery schedules, quality issues and providing competitive cost proposals

Confidential, Foothill Ranch, CA

Quality Assurance Manager, (Contract)

Responsibilities:

• Reported to Guthy Renker Corporation Quality Director and CPU2 Packaging Division General Manager
• Provided leadership and direction in management of QMS assuring compliance to US FDA,CFR Title 21, cGMP, and OSHA safety standards
• Provided daily supervision, training, and mentoring of 12 Quality Control inspection staff over 2 shifts and 9 packaging lines to ensure compliance to internal SOP's and national standards
• Directed quality responsibilities for new product qualification, customer approvals, certification, packaging POC's, and release
• Created internal calibration program and internal QSC Group (Quality Steering Committee) comprised of department managers to ensure continuous facility support of QMS by offering department managers a voice and involvement in quality direction programs affecting facility Improvements
• Right staffed organization bringing in technical expertise where needed and realigned departments to achieve operational goals and cost savings

Confidential, Corona, CA

Quality Assurance Director

Responsibilities:

• Hired for new Director of Quality position leading German Printing Industry supplier supporting Sheet Fed and Web printing applications
• Planned and directed ISO-9001:2000 quality system for two domestic facilities with 225 combined workforce
• Reported to USA subsidiary President and Strasberg, Germany corporate quality VP
• Skillful implementation of RMA and Internal Quality Cost Program and In-plant Loss Program that identified, tracked resolution of quality opportunities, improved internal quality costs, saving approximately $400,000 the first four months of an annualized $600,000 cost.
• Developed and implemented quality metrics for monthly plant and division levels reporting to top management
• In-plant loss program was also used to prioritize R&D work and justify expenses to correct problems
• Lean manufacturing & Kaizen team member utilizing mistake proofing and Poka Yoke strategy
• Organization Quality representative during third party ISO-9001:2000 and Customer Product Audits Improvements
• Implemented Customer Service Resolution Tracking System resulting in projected $1.5 million or 30% savings over the next year, by reducing field service costs approximately $325,000 through itemized tracking that off-set warranty expenses by customer; warranty type, plant, location and costs

Confidential, Placentia, CA

Quality System Engineer

Responsibilities:

• Maintained ISO/TS16949:2002, and AS-9100 product quality standards & specifications. Support PPAP generation and maintenance in back-up Automotive Engineer role
• Reviewed customer contracts to ensure requirements can be delivered
• Revised and Maintained Level quality assurance manual (QAM), quality assurance procedures (QAP), quality work instructions (QWI), forms, processes, Manufacturing methods
• Instruct personnel in matters relating to the use of inspection methods and equipment
• Managed internal audits, auditor certification training, performed supplier quality audits and maintained Supplier Scorecards
• Managed customer supplier survey questionnaire and record storage
• Provided surveillance of inspection methods and process control of shop floor/assembly processes. Provide analysis on SPC control chart data and establishment of control limits
• Performed special statistical studies: statistical tolerance analysis, tests of significance, design of experiments, failure analysis
• Prepared quality plans for specific work orders: Automotive, Aerospace and Commercial.
• Assisted in the development and continuous improvement of automated planning and engineering systems
• Generated Timelines and/or Milestone Charts (Microsoft Project) to organize and report status of personal backlog and of tasks/projects
• Troubleshoot day-to-day issues that hinder quality department performance
• Lead Lean manufacturing and Kaizen Teams through internal projects that increased mfg. floor efficiency
• Organization management representative for third party audits and Government Source inspections
• Managed Military - Defense Form-DD250 generation, presentation and record management Improvements
• Implemented a new product industrialization process (gate phased approach) to assure program milestones and cost targets are achieved