SUMMARY

• An engineering position with a company that offers a challenging and progressive work environment and it is a leader in innovation by allowing creativity and organizational flexibility.
• 15+ years experience as quality, manufacturing and project engineering in a fast paced, rapidly expanding companies.
• Expertise includes training and auditing to ISO9000/1,/2, /3,/6, /7, ANSI/ASQ Z1.4, ANSI/ASQC Q10011 - 1/-2/-3, MIL-STD1520, FAR, DFR GMP, FDA 21 CFR 820.50, 13485, 14001, 18001, IPC-610, J-STD-001, IPC/WHMA-A-620 requirements, supporting sustaining products, new products and product transfers.
• Reviewed/approved engineering design drawings and specifications for translation into program quality requirements and prepared procurement documents and manufacturing instructions for products from initial design phases through qualification and final design approval.
• Verified customer drawings and contract/Purchase order requirements and provided feedback and guidance for correction and accuracy.
• Provided real-time, creative engineering solutions for complex non-conformances which reduced MRB rate with 20%.
• Developed and designed an MRB Database to Monitor product throughput efficiency time and reduce the Cycle Time from 29 days to 21 days.
• Improved Procurement Process Efficiency by 15 % by reducing the time of creating quality documents attached to purchase orders flown down to suppliers.
• Improved manufacturing Process Efficiency by 30% by implementing SPC, control monitoring and Design of Experiment techniques.
• Provided support to meet functional, quality and reliability requirements for purchased components and supported supplier qualification.
• Managed Honeywell quality and achieved 0 defects for 4 weeks in row by reducing the PPM from 260000/week to 25000/week.
• Managed Hewllet-Packard quality and achieved for 6 months under 50 PPM and improving the yield by 20%. Production Revenue improved by $432K or a 42% improvement.
• Achieved 100% Customer Satisfaction rating in Supplier Scorecard Programs and won the Best Customer Focused Team of 2000.
• Applied customer specified quality programs to customer products such as AlliedSignal Total Quality Program, Hewllet-Packard Big Shot QA, and Tektronix Quality through paper work. Participated in Six Sigma implementation team.
• Reduced manpower from 5 to 3 by implementing progressive build.
• Improved operator efficiency by cutting 1.5 hours/day by implementing on line documentation system.
• Management, policy analysis, problem solving, budgeting, decision-making.
• Strong verbal and written communication skills across organizational lines.
• Multi Lingual-English, French, Romanian.
• Emerging authority in leading the QA and QC in Medical, JPL/NASA Aerospace, defense military, Electronic manufacturing device hardware from development to production.
• Knowledge of engineering fundamentals in, Fluid Mechanics, Structural Mechanics, Materials and Processes, Heat Transfer, Physics and Chemistry, Electronics and Manufacturing Processes.
• Evaluate, Approve, Audit and Training so as to maintain Suppliers ISO and NADCAP process QMS Certifications.
• Proven expertise in mechanical/electronic engineering design and manufacturing.
• Multi-tasking, analytical, proactive mindset built on a sound engineering background.
• ISO9001/9002, AS9100, cGMP/FDA, 13485, Certified Lead Auditor with Medical Device.
• Leadership, ability to achieve quality through prevention not through inspection.
• AUTOCAD LT 97, Prime CAD Medusa system, GC Preview, UNIX Reflection XCYMBRIDGE system, MRP, Microsoft Access, Excel, Power Point, Word, Microsoft Project, PDM system, E-matrix
• Certified IPC IPC-610 Trainer, Project Leadership certified by Institute of Electrical and Electronics Engineers.
• Lean Six Sigma Continuous Improvement projects.

PROFESSIONAL EXPERIENCE:

Confidential, Bothell WA

Sr Quality Engineer

Responsibilities:

• Perform Failure Modes and Effects Analysis (FMEA) of product designs. Provided quality and pricing input in complex Proposal documents including writing applicable proposal sections for contracts.
• Negotiate Engineering Work Requests (EWR) scope and budget requests. Elected as an MRB chairman I have provided concurrence on all Use As Is, Conditional Use as Is, Rework and Repair MRB dispositions.
• Supplier quality responsibility included approval audit, source inspection and Supplier Corrective Action Request. Generated QARs (quality assurance requirements) for parts and subassembly using customer quality clauses.
• Assisted suppliers in preparation of data packages submittals and review/approve them. Interpret and evaluate traceability, standards, measurement errors and integrity of standards and measurements.
• Inspect hardware for final receiving inspection and DCMA (defense contract management agency) inspection for final delivery to customer. Review final product Functional Test Protocol and review/approve test anomalies.
• Generated Certificate of Conformance for final product delivery in accordance with customer Purchase Order and Contract requirements.

Confidential, Redmond WA

Sr Quality Engineer

Responsibilities:

• Reviewing and approving PFMECA, Sequence of events and Method sheets as part of AED LP12 Process Validation/Qualification Plan. Providing leadership and direction to cross-functional teams in the effort of Investigating Problems to Root Cause and Planning Corrective Action.
• Facilitating weekly/monthly multi-functional AED LP12 Quality Data review to analyze measures relevant to the device or process responsibility.
• Review quality data records for CAPA and SCAR opportunities. Managing the planned measurement system for LP12 by weekly analysis and updates of the product and process centric measures.

Confidential, Redmond WA

Sr Quality Engineer

Responsibilities:

• Develop processes and systems that ensure the quality, reliability and safety of products and services. Analyze requirements for the development or modification of methods, procedures and metrics needed to ensure
• Quality System integrity and business process management objectives are met. Identify Program Quality risk issues. Investigate nonconformities that have been identified from the analysis of final inspection and test reports and customer complaints of product.
• Recommend and support the implementation of actions to design specification necessary to reduce or eliminate nonconformance. Conduct internal audits-test and SOPs. Wrote standard Operating Procedures (SOPs) and Work Instructions.
• Train personnel performing final inspection activities covering the requirements of IPC 610. Conduct internal audits. Safety committee chairperson.

Confidential, WA

Project Engineer

Responsibilities:

• Performing Design from Manufacturing (DFX) analysis on products scheduled to enter the production process, control and monitoring of the 1st Article process, and implementing process changes to ensure successful introduction of products to volume production. Monitor and coordinate all 1st Article production activity throughout the build process. Developing manufacturing Process Flow. Develop and drive changes to address Capacity Constrains of products.
• Design and order Tooling such as wave fixtures, Stencils, Jigs, Dies, Pallets, and Inspection Templates. Manage product Quality throughout the process and report significant issues to customers. Verify all manufacturing documentation for production floor. Define Special Processes and develop documentation to support. Coordinate and develop Product Quality Plan and monitor its implementation. Perform Labor analysis for new or existing product to develop Man-Power Plans for implementation.
• Identify major cost constrains for product, develop plans to reduce or eliminate and drive overall lower product cost. Perform production operator training Validate and implement engineering changes orders to customer products.

Confidential, WA

Configuration Control Analyst

Responsibilities:

• Perform analysis and scheduling of change order implementation based upon variables affecting manufacturability, quality and delivery. Coordinate with customers on design changes and respond to their requests.
• Negotiate and problem solve with internal and external customers to set implementation to execute change order. Communicate change order scheduling with multiple groups to ensure capacity, machinery, materials and optimized process.
• Analyze and recommend new process to decrease cycle time ECOs activity. Designed flow chart, which helped identify bottlenecks in processes. Provide engineering support to production group and support the resolution of production difficulties.
• Maintain and organize configuration, materials documents and database files. Work closely with sales, communicating cost and manufacturing impact. Interface with test engineers and inspection group during the production process.
• Using MRP for presenting recommended actions, creating and following up on manufacturing orders. Responsible for the integrity of the Bill of Materials and Item master. Leading technical and implementation MRB teams.