We provide IT Staff Augmentation Services!

Quality Engineer - Lead Quality Auditor Resume

4.00/5 (Submit Your Rating)

TX

SUMMARY

  • Successful Diversified experience in manufacturing operations, Medical applications & devices, to include aircraft commercial and government applications,
  • Project Management Body of Knowledge (PMBOK), Supplier Quality, Statistical Analysis, Systems Engineer.
  • Managed production, engineering, quality, multi - site groups of over 100 employees for developing scope, scheduling, plans, hardware, software and system level audits for compliance to
  • Quality Management System (QMS), ISO standards.
  • Experienced in advanced Lean principles and Value Stream Mapping (VSM).
  • Experienced with Federal Aviation Administration (FAA) Regulations, 3rd. Party Logistics (3PL) Inventory systems.
  • Managed supply chain order points and tracking of material handling warranty claims and Customer support.
  • Highly experienced on Root Cause Corrective Action (RCCA), quality source selection, process capability, assessments of suppliers and supporting business decisions in field operations.
  • To include CDL Class A with tank endorsements.
  • Performed and experienced in a culture of continuous improvement in team environments delivering results.
  • Managing leading and facilitating process improvement efforts with suppliers using established lean principles, processes and tools implementing production systems.
  • Supported advanced continuous improvement tool application.
  • Developed, maintained relationships and partnerships with customers, stakeholders, peers, suppliers and partners.
  • Coached, trained and motivated cross-functional teams. Instructed and assisted with teaching others in continuous improvement tools, assessing capability and capacity goals.
  • Participated and lead strategy development.

PROFESSIONAL EXPERIENCE

Confidential

Quality Engineer - Lead Quality Auditor

Responsibilities:

  • Quality Engineer Performing Registrar Audits for all regulatory agencies, working with MRO and OEM equipment.
  • Following up ensuring compliance to customer and (FAA) Federal Aviation Administration notifications.
  • Reviewing & approving process routers, developing quality plans, inspection records, review of purchase orders.
  • Reviewing and document nonconforming products, closing of NCR s & tracking for elevation to CARs (Corrective Action Reporting), writing CARs & CAPAs (Corrective Action & Preventive Action) for system or repeating product failures,
  • Driving Root Cause, print & engineering, machine or tooling changes.
  • Conducting process audits assuring adherence to Process specs, correct materials, assuring all signatures and attaining all necessary paper work.
  • Conducting internal system audits and audit of suppliers to include CAPA reporting and the response of these. Working with release of shipments assuring complete 8130 documentation, assuring that external audit findings are closed promptly to the satisfaction of the customers.
  • Reviewing of customer returns entering into CAR system assuring closure. Assuring compliance to EHS policies and applicable regulatory and company requirements, supporting ACE program Kaizens.
  • Reporting to management conditions or practices that are either unsafe or that may adversely impact the environment, ensure prompt resolution of potential hazards.
  • Working with AS9100, ISO9000, to include (CAAC) China Civil Aviation Regulation, (THAI) The Civil Aviation Authority of Thailand and (EASA) European Aviation and Safety Regulatory Standards.

Confidential

Quality Engineer

Responsibilities:

  • Quality Engineer control point for the analysis, reporting and training of Composites product line.
  • Quality improvement projects and Lean Kaizen events improving product line.
  • Design specific to inspection and testing mechanisms and equipment; analyzing production, service limitations and standards, recommending revision of specifications, formulating quality assurance policies and procedures. Conducting training on manufacturing quality assurance, Lean manufacturing, SPC concepts and tools.
  • Reviewing and signing Engineering Change Notices (ECNs) and engineering drawings.
  • Working with QC and production personnel driving continuous improvement process.
  • Tracking: ensuring measurement and testing equipment used within the division is within calibration.
  • Monitoring and assisting First Article Inspection (FAI) information system.
  • Writing reports and standard work, conducting statistical analysis. Providing Data analysis and reporting.
  • Ensuring production tooling is inspected and conforms to specs prior to use.
  • Approving work orders prior to release ensuring engineering operations are properly documented.
  • Applying purchase order quality clauses to applicable products with in MRP system (Royal IV).
  • Assisting Corrective Action Board (CAB), providing problem solving / resolution.
  • Performing internal process audits to company specifications.
  • Familiar with Windows Operating Systems, Office, and MRP systems. Good trouble shooting skills and strong communication skills.
  • Experienced in reading engineering drawings, specifications and other related literature.

Confidential

Supplier Quality Specialist, Quality Systems Specialist

Responsibilities:

  • Quality Engineer responsible for training to include training documentation, reporting, managing supplier related activities, planning, Quality Audits (documentation and follow up), FAA assessments and inspections for Confidential KC135, C10, 787 and 747 aircrafts.
  • Quality and Supplier, Planner, writing Emergent Removals (ER), shop order instance revision request (SRR), Pick - ups for disposition and revisions of documents.
  • Supported Manufacturing Engineering and Liaison Engineering Validating Shop Order Instances (SOI), RCCA, and Emergent Process Documents.
  • Reviewing adherence to occupational safety, health, Material Review Board (MRB), QMS using Web-based enterprise systems like ISIS, TIPQA, WASA, EPES, WOW, OWI, NCM, 5S, Confidential, CATIA, REDARS and Velocity. Lead of Employee Involvement (EI). DCMA for Confidential C17, KC135, KC10, 787, 747 and C130 Aircraft.
  • Conducting research and source selection supporting business decisions on all Quality matters to include Composite materials.
  • Worked improvements as a project manager assessing capability and capacity of suppliers.
  • Supported manufacturing leadership, field operations, supplier management, planning and other groups by utilizing Lean+ principles.

Confidential

Quality Engineer

Responsibilities:

  • Quality Engineer responsible for development and improvement of Regulatory Standards: AS9000, ISO9000, to include United Arab Agency Emirates (UAE), General Authority of Civil Aviation (GACA) and European Aviation and Safety (EASA) Regulatory Standards.
  • Where GDC holds certificates for the installation and renovation of Aircraft interiors customizing the Aircraft to customer requirements.
  • Assuring these were in adherence to the corresponding certification, in addition to the auditing of the various aircraft in modification status, to include special FAA assessments and inspections.

Confidential, TX

Lead Service Desk Specialist

Responsibilities:

  • Liaison of district support and Technology Information systems, investigation, resolution of computer, network, Electronics repair, student accounting,
  • Estimating and pricing, finance, software, and hardware.
  • District Antivirus Project Manager. Configuration Data and Project Management.
  • Updated, and presented Microsoft and Apple office applications. Implemented and maintained process improvements by analyzing and establishing Information Technologies (IT) best practices.

Confidential, TX

Program Manager / Quality Engineer.

Responsibilities:

  • Medical environment: Managed the ISO 9001 and ISO 13485 policies and procedures on Medical Molding equipment, analysis on equipment and software, procedure implementation of Food Drug Administration (FDA) regulations in a medical environment. MRB validations and implementations.
  • Project Management, traveling within facilities (Internationally) addressing supplier RCCA, validations, Electronics repair, transferring of specialized equipment.
  • Presentations to upper management and stakeholders of analysis, process data, metrics, models. Delivering results, driving business results.

Confidential

Operations Supervisor II.

Responsibilities:

  • Managed production planning schedules, standard costs and standard operations.
  • Analytical projects presented to upper management. In charge of Quality Department,
  • Molding, RCCA, auto insertion, SMT Top/Bottom, STK Lead, Wave Solder, final assembly and operations in home entertainment and automotive division.
  • Developed and optimized inventory levels. Performed product and process audits.
  • Electronics repair, Coordinated and authorized release of orders.
  • Implemented and improved Supply Chain Management (SCM) performance.
  • Applied SCM methodologies to ensure coordination in the Confidential supply chain. Analyzed complex material requirements and excess inventories.
  • Managing conflicts, motivating others.

Confidential

Production Manager

Responsibilities:

  • Responsible for strategic adjustments to operation plans, adhering to FDA and OSHA requirements, executive reports.
  • Considerable improved product and process acceptance though the use of Design of Experiments (DOE). Project Management, Managed work and employee motivation.
  • Driving Business Results.
  • Analyzed the current and future business environment and develop forecast, acquisition, and utilization plans to optimize resources in support of company initiatives and program business plans.
  • Developed and maintained complex Business System factory definition used for manufacturing to include planning.
  • Developed labor hour estimates for new or revised production and tooling work packages by utilizing labor standards, tool and production design drawing reviews, tool and Production Operations concurrence to support program business plans. Monitored performance.
  • Participated in development of integrated tool and production master schedules by developing tool and position plan, documents, contract review, tool downtimes, rate flow, identified and implemented improvements to processes by analyzing current processes and utilizing established improvement methodologies to maximize efficiency of equipment and personnel to support company improvement initiatives.
Confidential

Manufacturing Facilitator.

Responsibilities:

  • Medical Environment: Developed teams in Medical environment for customer demand, quality, cycle - time and FDA, product manufacturing, implemented Continuous Flow Management (CFM), TQM and Just in Time (JIT). Modified procedures following Good Manufacturing Practices (GMP) and ISO requirements in a clean room environment.
  • Interacted with engineering on product, process, procedures, validations, deviations, inventory accuracy, revised metrics, OSHA implementation and RCCA.
  • Developed teams in quality, auto Insertion, compliance to standards, cost savings and labor reductions.
  • Researched, compiled and analyzed performance reports, process control and statistics for continuous improvement of process capability.
  • Creating a culture of continuous improvement leveraging employee engagement improving employee job satisfaction and customer satisfaction. Coached, counseled, mentored and provided developmental opportunities and job assignments enhancing employee performance capabilities in a medical environment. Provided on-going developmental feedback.
  • Recognized contributions of individuals and teams improving employee satisfaction to retain skilled and motivated workforce.
Confidential

QA Liaison Engineer.

Responsibilities:

  • Implemented systems improving QA processes, procedures, products and the total facility.
  • Responsible for approval by body agencies, OSHA, ISO 9000. Lead Assessor of QA systems, Standardized Statistical Process Control (SPC) systems, new product, documentation, QA audits lead (Documentation and follow up), and RCCA. Subject Matter Expert (SME) in quality matters regarding regulatory compliance.
  • Designed and deployed Prediction by Partial Matching (PPM) data.
  • Coached and supported group leaders, facilitators and supervisors on software, hardware applications, monitoring of productivity, customer satisfaction, lean principles, metrics, TQM encompassing Problem Solving Process (PSP), Quality Improvement Process (QIP), and Effective Facilitation Skills (EFS).
Confidential

Sr. Supervisor.

Responsibilities:

  • Established report systems. Trained personnel on SPC and Six Confidential .
  • Implemented total customer satisfaction teams addressing investigations and RCCA.
  • Established tooling and product support departments.
  • Managed database, generated damage log reports, provided CA.
  • Developed processes and procedures for the formulation and baking departments via utilization of CAD software.
  • Provided cost reductions and training to peers and group leaders on various software applications. Achieved 80% reduction of tool damage.
  • Developed and executed business plans, policies and procedures developing organizational and technical strategies improving supplier performance.
  • Acquired and managed resources and lead process improvements.
  • Developed and maintained relationships and partnerships with customers, stakeholders, peers, partners, suppliers and direct reports.
  • Supported crew cycling, learning curves, shift analysis, optimum crew size, and tooling capacity.

Confidential

Quality Control Manager

Responsibilities:

  • Managed teams of over 100 employees, members were Mechanics, Operators, Engineers, Supervisors and technicians in establishing innovated processes and product audits utilizing.
  • Knowledgeable on Auto CAD. Managed areas of assembly, finish (paint) rooms, hardware, electrical, test, and final inspection of molded products.
  • Implemented a World - Class Quality Team in every area, to include mechanical, industrial, electrical, and manufacturing engineers.
  • Responsible for budget, cost, analysis of systems data, department metrics, training, validation of processes and procedures.
  • Created and implemented reports, milestones and systems for RCCA. Provided certifications to suppliers and MRB.
  • Responsible for continuous improvement of processes and procedures to reduce cost.
  • Managed employees and first-level managers performing supplier quality activities ensuring suppliers' production and quality systems, special processes, products and services meet purchase contract requirements and applicable regulatory agency and government regulations.
  • Developed and executed business plans, policies and procedures, developed organizational and technical strategies to improving supplier performance.
  • Provided education and coaching on Quality System. Acquired and manages resources that lead process improvements.
  • Developed and maintains relationships and partnerships with customers, stakeholders, peers, partners, suppliers and direct reports.
  • Managed, developed and motivated employees, engineers and first-level managers. Analyzed changes to approved plans resulting from unplanned events.
  • Assesses the impact of changes that occurred to cost, schedule, resources, and delivery.
  • Develops modifications to existing plans and obtained approval for plan changes.
  • Participated in negotiations representing Production and Tooling Operations to support schedule commitments or statement of work impacts

Confidential, TX

Manager, Supervisor, Electronics Technician, Inspector

Responsibilities:

  • Manager, Supervisor, Electronics. Technician, RI Inspector, seat, hardware, galley inspections.
  • Responsible for QA, manufacturing, production, planning, warehouse, test, data analysis, rework and finished goods.
  • Managed, trained, scheduled, motivated and directed over 55 employees including QC, receiving, process and product inspection.
  • Tasks included SPC, DOE, ComCAD, Auto Insertion in top and bottom Surface Mount Technology, Welding/Soldering, Data, Information and Process integration (DIP),
  • Radial / Axial, Sequencers equipment, programming, scheduled maintenance, implementation and documentation of RCCA.
  • Develops and uses process analysis and measurement techniques to evaluate and improve the efficiency and effectiveness of resources.
  • Presented performance data and recommendations to superiors for resource allocation decisions.
  • Analyzed impact of process changes to assure accuracy of budget projections.
  • Managed use of approved processes and coordinates integration of changes to processes.
  • Developed and applies labor standards to production orders.
  • Developed shop floor layouts. Coordinated with affected organizations to ensure resource availability.

We'd love your feedback!