ISO 9001 Quality Management Systems Design, Implementation, Auditing

(California Legislature Assembly Bill) AB 1282 | Six-Sigma Project streamlining the CalTrans - CEQA / CDFW Environmental Permitting Process.

Design and implementation of a ISO:9001:2015 based QMS. Map current processes from receiving through shipping. Perform GAP analysis, process mapping, design and implementation of a document control system. Created Quality Manual and level 2 SOP's, updated and created procedures, work instructions and forms. Obtained approvals and provided training on the aforementioned.

Responsible for all Excalibur missile program quality related functions.Responsible for managing non conformance (NC) & corrective action (CA) databases.Represent the quality department in Integrated Project Team (IPT) meetings.Organize and chair Material Review Board (MRB).Organize and chair program Corrective Action Board (CAB).Customer point of contact (POC) for all program quality related issues.

Lead and manage all Quality functions at EPT Research & Development / Rapid Prototype facility.Solely responsible for the development and implementation of the ISO 9001:2015 Quality Management System and obtaining third party registrar certification.Solely responsible for the quality planning and support of the (JSF) Joint Strike Fighter, Advanced Onboard Electronic Warfare (AOEW), and Laser Pod Research & Development (LPRD), Navy Energy Magazine Prototype (EM-P), NOAA, and other projects.• Worked with suppliers’ Quality, Engineering, and Manufacturing personnel to improve suppliers’ performance in terms of quality and efficiency as primary quality interface with customers and suppliersAccomplishments:1. Created all required QMS documents, obtained approvals from process owners, and provided training.2. Implemented document control system & made all engineering documents & Instructions accessible to employees.3. Mapped and streamlined assembly processes.4. Created travelers with inspection and quality control criteria.5. Maintained all project documentation.6. Championed ISO Stage 1 & 2 registrar audits with minimal findings.

Responsible for the development and implementation of ISO 9001:2015 QMS and obtaining a current ISO 9001 certificate from a third party registrar.Responsible for the companies adherence ISO 9001:2008 QMS as well as preparing for the ISO 9001:2015 transition and certification activities.Oversee Internal Audit / Corrective Action program Responsible for providing improvement criteria, oversee upgrading and maintaining the SolidWorks PDM Document Control system.

Responsible for engineering QA & QC processes on the H.A.R.T. (Honolulu Area Rapid Transit) project.  • Responsible for obtaining ISO 9001, 14001, & 18001 certificationsAccomplishments:1. Defined roles and responsibilities and standardized cross-functional business processes.2. Designed and implemented processes to enhance the control of product non-conformances and prevent quality escapes.3. Streamlined calibration recall system to enhance effectiveness, reduce costs and equipment downtime.

Responsible for all aspects of ISO 9001:2015 / TL 9000 Quality Management SystemsCorporate safety manager & Cal/OSHA representativeStreamline business and execution processes to maximize efficiency and qualityCompose and present corporate quality metrics to upper managementOversee internal auditors & audit / CAPA programPrimary quality interface with customers and suppliersOversee document control, incoming, in-process, and final inspection departments.Pareto internal defects and identify training needs and assure employees are adequately trained.Accomplishments:1. Updated all outdated QMS documents and obtained approvals from process owners.2. Created document control & made all Work Instructions accessible to all employees.3. Mapped and streamlined 3 corporate value streams4. Obtained ISO 9001:2015 /TL-9000 re-certification.

Developed processes and procedures required to obtain ISO 9001 certification Manage all ISO 9001 as well as elements of ISO 13485 & TS-16949 QMS. (PFMEA, CpK. Control Plans, Process Maps. PPAP, APQP, etc.)Oversee all AIAG processes for automotive division.Corporate representative on all customer audits as well as lead auditor and manager of the ISO 9001:2008 / TS-16949 internal audit program.Provide corporate quality performance metrics e.g. First Pass Yield, Final Inspection, Rework, Scrap, Customer Returns, etc. and ensure knowledge distribution and sharing among Upper Management & Internal Manufacturing Managers.Responsible for training & managing a team of 30+ inspectors and quality engineers.Managing Corrective Actions and preventing re-occurrence using a variety of problem solving methodologies and collaborating cross-functional teamwork and communicating these solutions to the customer.

Execute and manage all ISO 9001:2008 / TS-16949 QMS activities necessary to support Manage and report all QA budget and cost savings activities.Design and implement Business Processes throughout the organization. Process mapping, value stream mapping, writing procedures & work instructions, training, data collection/analysis and continuous improvement projects. Lead all corporate Quality Management activities for CNC, Fabrication, Bolt, Solder, Copper Core, Aluminum Core, & Aluminum Weld factories.Provide corporate quality performance metrics e.g. First Pass Yield, Final Inspection, Rework, Scrap, Customer Returns, etc. and ensure knowledge distribution and sharing among Upper Management & Internal Manufacturing Managers.Manage Returned Goods Authorization (RGA) personnel and process. Provide metrics on performance to satisfy customer returns.Responsible for managing Corrective Actions and preventing re-occurrence using a variety of problem solving methodologies and collaborating cross-functional teamwork and communicating these solutions to the customer.Review contracts and specifications and work together with Sales and Engineering to ensure new products are developed in compliance with customer requirements.Serve as JBRS corporate representative on all customer audits as well as lead auditor and manager of the ISO 9001:2008 / TS-16949 internal audit program.Chair Material Review Board and collaborate with Engineering, Purchasing, and Logistics to ensure Non-conforming materials are processed expediently. Oversee document control, final inspection, personnel and processes.Designed and implemented Customer Complaint database.Accomplishments:1. Streamlined RGA process to achieve turn-around and improve customer satisfaction.2. Designed and implemented daily GEMBA walks in all factories.3. Streamlined calibration recall system to enhance effectiveness, reduce costs and equipment downtime.

Responsible for ISO 9001:2008 QMS compliance / registrationCommunicating job expectations and enforcing policies and procedures.Met quality assurance financial objectives by estimating requirements, preparing an annual budget, scheduling expenditures, analyzing variances, initiating corrective actions.Developed quality assurance plans by identifying critical control points and preventive measures, monitoring procedures, issuing corrective actions, and completing verifications.Validated quality processes by establishing product specifications, writing and writing and/or updating the necessary quality assurance procedures.Improved product quality by completing surveillance audits, investigating customer complaints, and collaborating with other members of the management team to develop new products and improve engineering designs and manufacturing methods.Prepared quality documentation and reports by collecting, analyzing and summarizing information and trends including customer returns, corrective actions, and rework.Accomplishments:1. Defined roles and responsibilities and standardized cross-functional business processes.2. Designed and implemented processes to enhance the control of product non-conformances and prevent quality escapes.3. Streamlined calibration recall system to enhance effectiveness, reduce costs and equipment downtime.

Insured that the correct quality requirements and specifications are called out on the drawings, purchase orders, and contracts before their transmission to suppliers.Evaluated and advised on design for quality as well as cost reduction and process streamlining. Responsible for the control of Product Quality Assurance related project costs, scheduling, and fulfilling contractual quality requirements on assigned projects. Worked cross-functionally with other suppliers, material managers and production / manufacturing engineers to resolve quality issuesWorked with suppliers’ Quality, Engineering, and Manufacturing personnel to improve suppliers’ performance in terms of quality.Implemented, executed, and managed a root cause analysis and corrective action processes in-house as well as on supplier’s parts and quality escapes.Evaluated existing and potential suppliers’ quality management systems using a combination of Supplier Surveys, off-site QMS audits, as well as on-site QMS audits.Qualified suppliers and maintained the Approved Supplier List (ASL).Developed, maintained and reviewed Supplier Metrics and worked with suppliers to overcome deficiencies. Managed suppliers’ non-conformance, including disposition and documentation.Responsible for Counterfeit Parts Risk Mitigation Program.Accomplishments:1. Performed root cause analysis and validated effectiveness on several complicated issues.2. Implemented preventative actions to reduce scrap in Breech-Lok assembly by >90%3. Researched product line and championed change to alternate conductive epoxy. ($13,600.00 on-going annual cost-reduction)4. Designed, developed and evaluated a new production process. ($67,000.00 on-going annual cost-reduction)5. Implemented scrap tracking and trending and used data to identify problem areas and trigger corrective / preventative actions.

Reviewed and approved inspection/test data.Maintained inspection records in accordance with procedures.Read and interpreted mechanical drawings and procedures.Generated and assisted in the corrective/preventive action process.Organized and presented nonconforming materials and associated docs in MRB meeting.Supported the ISO 9001:2008 Quality Management System.

Review customers' specifications during Request for Quote (RFQ) and Contract Review stages for needed clarifications, translate and communicate those requirements into clear and concise instructions, and conduct any necessary training to affected personnel. Maintain customer quality profiles including customers' specific process requirements, quality clauses, approved deviations, waivers, etc. Ensured specifications were up-dated; coordinated this activity with Non-Destructive Testing (NDT) technicians and Quality Engineers.Process mapping, value stream mapping, writing procedures & work instructions, training, data collection/analysis and continuous improvement projects. Wrote and executed NDT predictive maintenance plans per specific customer needs.Performed Thermal Imaging (TI) data analysis and reporting using Fluke “SmartView” software.Worked with Suppliers and internal staff from other departments to ensure raw materials and finished products met company and customer specifications. Utilized soft skills when dealing with customers, management and internal peers and subordinates to solve problems using win-win approach. Analyzed and reported KPI's before management meetings and reviews. Ensured that adequate training was available to all employees concerning Quality Awareness and Customer Satisfaction.Responsible for the procurement and calibration of NDT testing equipment.Developed and validated thermal imaging analysis methods and test procedures.Wrote Control plans and Project Configuration validation plans.Reviewed for compliance and processed all vendor project-material submittals.Responsible for Government / USACE Product Configuration Acceptance (PCA)Accomplishments:1. Responsible for acquiring initial ISO 9001:2000 certification.2. Promoted from Quality Inspector to Quality Engineer and onto Quality Manager.3. Responsible for maintaining customer satisfaction and quality relations.