Andrew Inenaga Email and Phone Number
Experienced Leader of Quality with a demonstrated history of working on optical / mechanical / electrical / software driven systems. Reliability Engineering, Continuous Improvement, Product Development/Design Controls, and Team Building. Strong quality assurance professional graduated from University of California, Berkeley. Currently enrolled in Medical Device Certificate, ISO 13485, FDA 21 CFR 810, PMA, cGMP, cGLP, cGCP, Design Controls, Risk Analysis, 14971, 62304/82304, Human Factors and Useability.Proven ability to develop and implement a strong Quality Management System (QMS) from the ground up. Excellent at developing strong relationships with both internal and external customers at all levels of the organization to create targeted and effective processes and systems. Broad background in various Quality Engineering disciplines including 8D problem solving, statistical process control (SPC), and supplier management. Years of experience in RMA management and product failure analysis. Utilized a software programming background to design, develop and deploy world-wide QMS solutions for corrective actions/CAPA, SPC, WIP management and RMA analysis. ACCOMPLISHMENTS:- Implemented and utilized SPC to drive down product variation by 150%- Established test facility for surveillance analysis of manufacturing, test and New Product Introduction (NPI) / Design Controls- Lead an NPI/Design Controls based development process to drive lead time improvements by 50%CORE COMPETENCIES:QualityDesign Controls / New Product IntroductionReliabilityMethodical/Technical Problem SolvingTeam LeadershipQuality PlanningCopy ExactPlease contact me at 408.306.5794 or aeinenaga@gmail.com with any inquiries for Quality/Reliability opportunities.
Cavnue
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QualityCavnue Apr 2023 - PresentWashington , Dc, UsDeveloped the Design and Manufacturing QMS from the ground up, including First Article Inspection, Change Management/Control, Supplier Feedback and Scorecarding, Dock to Stock programs, FMEA and Hazard/Harm Analysis processes. Deep dive failure analysis and 8D reporting of critical supplier and design issues, improving yields to 100%. Created and executed the Supplier Audit Plan and conducted On-Site audits, which drove Scorecard improvements > 98%. Instrumental in establishing Quality and Workmanship standards utilized across the entire product portfolio.
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QualityVelodyne Lidar Apr 2022 - Feb 2023Established and led the cross-functional team to create and continuously improve the New Product Development Process world-wide. Responsible for driving NPI D/PFMEA, Lessons Learned and Hazard Analyses throughout the company. Successfully drove the completion of the first development project in > 3 years for Velodyne. Created the framework and utilized the 8D process to improve Customer RMA rate > 90%. Tiger Team lead to drive mission critical product yields, and improved processes +25%.
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QualityEargo Sep 2020 - Apr 2022San Jose, California, UsLeadership role in customer complaints and failure analysis, driving down rates > 50% during product launch through effective Root Cause Analysis, supplier management, and SCARs. Created 13485 compliant NCMR and Post Market Surveillance process. Developed failure analysis processes for new products, including documentation of key root causes, test methods, KPI and systems startup. Key contributor to RMA backlog reduction effort which reduced the backlog > 30%. -
QualityComet Technologies Usa, Inc. Mar 2015 - Sep 2019Flamatt, Fribourg/Freiburg, ChResponsible for all facets of Quality from Suppliers, In-house and external manufacturing, ISO certification, CAPA, design controls and failure analysis of high power RF matching networks. Created custom web application for Real-Time Statistical Process Control (SPC), deployed world-wide, which decreased product variability by > 150%. Customer interface for all Quality-centric activities, including customer escalations, scorecards, 8D problem solving and process improvements. -
Quality And ReliabilityAurora Networks May 2004 - Mar 2015San Jose, Ca, UsEstablished complete Quality Management System in Manufacturing including Incoming/In-process/Final Inspection, First Article and RMA. Multi-site implementation of ISO. Developed in-house Quality database tools for tracking continuous improvement objectives. Reduced RMA rate 30% year over year. Improved key supplier’s scrap and RMA cost by > $1M/year. Established test facility for surveillance analysis of manufacturing, test and New Product Introduction (NPI). Direct customer interface for all Quality and Reliability issues. -
Quality And ReliabilityJds Uniphase 1998 - 2003Chandler, Arizona, UsPerformed Quality, Reliability and Failure Analysis for a vast product portfolio. Integrated with R&D, Manufacturing and Marketing in all phases of the new product development process including implementation of standardized DVT, DFMEA analysis, design and process reviews, in-process quality monitoring, incoming inspection requirements and establishing failure criteria. Established and lead a team for Failure Analysis. Lead and drove down RMA rate 50%. Built a world-class Reliability Engineering and Testing center. Lead auditor for ISO certification. Instrumental in the implementation of ISO/TL9000 Lead for Global CAR process within JDSU which incorporated the 8 Disciplines (8D) approach for root cause and corrective action.
Andrew Inenaga Education Details
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University Of California, BerkeleyMechanical Engineering -
University Of California, Santa CruzMedical Device Certificate
Frequently Asked Questions about Andrew Inenaga
What company does Andrew Inenaga work for?
Andrew Inenaga works for Cavnue
What is Andrew Inenaga's role at the current company?
Andrew Inenaga's current role is Quality | ISO 9001/13485 | SPC | Supplier Quality | 8D | Failure Analysis | Six Sigma | CAPA | NPI | RMA | Web Apps|.
What schools did Andrew Inenaga attend?
Andrew Inenaga attended University Of California, Berkeley, University Of California, Santa Cruz.
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