SUMMARY

• Supplier Quality Engineer with extensive experience in the Semiconductor Assembly - Test industry, Consumer, Medical Device, Automotive, Airport Security field dealing with electromechanical components, assemblies and PCBAs and advanced semiconductor packaging.
• Strong communication, technical writing, cross-functional product development, project management, organizational and presentation skills.
• Broad experience with internal/external supplier and customer audits with focus on process control and quality systems at both local and off-shore material suppliers, assembly subcontractors, SMT houses, contract manufacturers.

TECHNICAL SKILLS

Quality Management Tools: Statistical Process Control (SPC) concepts, Design of Experiments, FMEA, 5-S, Lean Manufacturing, 8-D Problem Solving, Mistake Proofing, DMAIC, Measurement System Analysis, 6-Sigma, APQP and CAPA process

Standards: Jedec, EIAJ, Mil 883, 38510, TS-16949, ISO-9000, QS9000, AS9100, ISO-13485, 21 CFR 820 and cGMP, MDD, CMDR, ISO 14971 (Risk Management for medical devices), IEC 62304, AEC Q-100, IPC-A-610, EU Standard for ROHS/WEEE/REACH, GD&T, ANSI/ASQ Z1.4.

PROFESSIONAL EXPERIENCE

Confidential, Newark, California

Sr. Supplier Quality Engineer

Responsibilities:

• Co-managed Gantry bearing quality and reliability programs that lead to at least 50% improvement of first pass yield at supplier sites and system integration sites. Aided in design improvements of key testing tools at supplier sites, internal production sites. Managed 3rd party lab testing for failure analysis including package integrity testing.
• Managed supplier yield and SCAR resolution for critical electro-mechanical components and led team of manufacturing engineering, mechanical/electrical engineering, planning, and supplier teams using PIO (Problem/Issue/Opportunity) project tracking system. Utilized SPC concepts and tests for significance techniques to qualify and validate process and material changes.
• Conducted supplier audits both domestic and international. And helped developed audit checklists and metrics tracking.
• Managed closure of Failure analysis and RCCA of field failed components utilizing company product complaint database.
• Wrote specifications and procedures related to supplier sourcing, control and monitoring of supplier quality. Co-developed procedures for SAP Quality Notification process for issuing/closing non-conformances, First Article testing procedure enhancements utilizing CTQs (Critical to Quality), assembly work instruction/testing and packaging improvements.
• Led quality team during K8/L7 (Lean manufacturing concept) projects to improve takt time, waste reduction and mitigate risks to quality and safety.
• Provided training for Suppliers on 8D Problem Solving, Lean Manufacturing, PFMEA

Confidential, Irvine, CA

Supplier Quality Engineer

Responsibilities:

• Managed the Critical Care Supplier Quality Compliance Excellence Project to assess and close gaps in supplier qualification files and SOPs in preparation for FDA audits.
• Coordinated the team of global supply management, RnD, Manufacturing Engineering, Quality and Regulatory staff in cleaning up all open supplier part change requests called SQRs (Supplier Qualification Requests) for all electromechanical components including PCBAs, fluidics, plastics consumables and service providers like Calibration and Testing labs, creating enhancements to the change evaluation, process validations, qualification and approval protocols plus the MRB and SCRB processes. Coordinating Tooling Fixture IQ, Test method validations OQ/PQ.
• Supported the monthly supplier performance management review activities presenting the KPIs including NCRs, SCARs, Supplier Warnings, Supplier audits, Field Corrective Actions, FDA Audit observations and closure. Utilized QMS system to track and manage SCARs, CAPA closure and effectiveness monitoring, NCRs, quality dashboards as well as Ignite PLM for part drawing change control. Provided failure analysis for non-conformances caught at incoming, in-process and outgoing quality inspection areas.

Confidential, South San Francisco, CA

Sr. Supplier Quality and Technical Operations Engineer

Responsibilities:

• Performed supplier selection, developed and completed new supplier and new device qualification projects as part of supplier approval and certification. Led new product introduction, integration and commercialization, design rule improvements, production ramp-up at Contract Manufacturers (CMs), PCBA houses and electro-mechanical, fluidics/optics component suppliers. Also responsible for Six-Sigma, Kaizen and cost reduction programs for critical suppliers using BKM (Best Known Methods).
• Performed periodic internal and external audits according to ISO standards 13485, 9001 and FDA "Good Manufacturing Practices” at both domestic and international sites. Defined requirements for Incoming, in-process and outgoing quality for CMs, established PCPs (Process Control Plans) and instituted periodic reliability monitoring.
• Played key role in New Product Introduction and Life Cycle Management from planning, design reviews to VnV (Verification and Validation) to Production transfer, design and document change control using Agile PLM according to ISO-13485 or 21 CFR 820 and ISO14971, packaging and labeling, completing product/component specs and test protocols, defining new die design, new process, new package qualification requirements for chip sensor devices, new PCB laminate design review and approval.
• Wrote IQ/OQ/PQ test protocols to qualify then validate new product design and processes, risk analysis and management per ISO 14971, establishment of technical documentation (DHF, DMR), Safety Compliance to IEC61010-2-101, EN 61326-2-6 for EMC as well as shipment transportation standards to ISTA, MDD, CMDR. Implemented dock to stock for instruments using AQL acceptance sampling (ANSI/ASQ Z1.4), Reliability test plans, First Article Inspection.

Confidential, Warren, NJ

Sr. Package Development Engineer/Supplier Qualification Engineer

Responsibilities:

• Responsible for executing NPI (New Product Introduction) for the wireless and broadband business units. Managed new chip/package/material/assembly process technology introduction, qualification. Process validation, design transfer to small to large scale production at off-shore subcons. .
• Conducted Design of Experiments to qualify new materials such die attach epoxy, mold compound, under fill, laminate material and establish a Bill of Materials for each supplier and drove improvement programs with Wafer Fab teams. Prepared assembly process specs, design rules for subcontractors.

Confidential, Framingham, MA

Sr. Supplier Quality Engineer

Responsibilities:

• Responsible for reviewing and qualifying suppliers of electronic commodities using PPAP (Production Part Approval Process) and evaluating supplier’s quality and reliability data and programs serving as supplier quality project leader for all NPI projects
• Worked with design engineering in establishing Design Validation and Process Validation testing requirements and monitoring. Conducted process control audits of contract manufacturing houses and design centers in US, Europe and Asia in support of the Automotive System division special projects and review of APQP and TS-16949 compliance.