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Six Sigma Black Belt certified business and operations leader. 15+ years of experience in class III medical device, aerospace/defense, high tech and consumer product industries. Progressive leadership experience in quality, design, manufacturing, supplier management, continuous improvement, regulatory compliance, audit, and customer service. Master’s Degree in Engineering.CAREER HIGHLIGHTS• Currently heading the Global Quality and Compliance organization for a $800 million hand tool business.• Led enterprise PPAP strategy and implementation for global NPD programs.• Established and executed global quality strategy for 350 finished goods suppliers, with $300 million annual spend.• Oversaw product quality from 10 manufacturing sites globally.• Established quality system at a 500k sqf warehouse operation.• Implemented and expanded quality programs with customers such as The Home Depot and Canadian Tire.• Headed global “Go Team” for quality issue disaster response and recovery.• Headed Global Supplier Quality organization for a $2 billion aerospace/defense business.• Directly supervised 25 quality engineers, managers, and auditors, across 6 aerospace manufacturing facilities.• Directly supervised 11 quality engineers and technicians to support a $600 million high tech equipment business.• Ensured product compliance to AS9100, ISO9001, ISO13485, CFR 21, and cGMP.• Audited medical device manufacturing sites for ISO13485 and CFR 21 compliance.• Led enterprise implementation and certification of ISO9001:2015 standard.EXPERTISEGlobal Operations Leadership, Supplier Quality Strategy, Policy Deployment, Enterprise PPAP and Quality System, Six Sigma, Lean Sigma, ISO13485, ISO9001, AS9100, Audit, APQP, Operations Excellence, Program Management.
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Director Of Global Quality And ComplianceApex Tool Group, Llc Oct 2021 - PresentSparks Glencoe, Maryland, UsApex Tool Group (ATG), headquartered in Sparks, Maryland, is one of the largest manufacturers of professional hand and power tools in the world, serving the industrial, vehicle service and assembly, aerospace, electronics, construction, and DIY markets. ATG is a private company, with about 7,000 employees, over 20 global manufacturing facilities, and approximately $1.3 billion USD in annual revenue. Summary: Headed Global Quality organization for the $800 million hand tools business. Responsible for quality output of 10 manufacturing sites in North America, Asia Pacific, and Latin America, as well as 350 global suppliers. Directly supervised corporate quality group and metallurgy lab. Headed North American Supply Chain and Customer Compliance organization. • Led corporate APQP/PPAP planning and execution. • Developed global process to assess, monitor, and improve 350 finished goods suppliers, in ML China, Taiwan, India, Vietnam, and United States. • Oversaw product quality from 10 manufacturing sites in ML China, Taiwan, United States, Mexico, and Brazil.• Created global “Go-Team” and headed quality issue disaster response and recovery.• Led global NPD (New Product Development) quality control via PPAP and other measures.• Implemented Quality System at a 500k sqf warehouse operation in Apex, NC.• Served as ATG customer facing quality authority, reduced warranty cost, and improved customer relationships.• Created North America supply chain and customer compliance organization, and governing management system. -
Sr. Global Quality ManagerApex Tool Group, Llc Jun 2018 - Oct 2021Sparks Glencoe, Maryland, Us -
Associate Director Of Supplier QualityUnited Technologies Oct 2017 - Jun 2018Farmington, Ct, UsUnited Technologies Corporation (UTC, NYSE: UTX), headquartered in Farmington, Connecticut, was an American multinational conglomerate with $57 billion annual revenue, and 201,000 employees. UTC Aerospace Systems was a division of UTC, with $14 billion annual revenue, and 41,000 employees. UTC Aerospace Systems was one of the world's largest suppliers of advanced aerospace and defense products. United Technologies is now Raytheon Technologies. Summary: Headed Supplier Quality organization for a $2 billion UTC Aerospace Systems business unit. Responsible for quality performance of 1,500 suppliers. Directly supervised 25 supplier quality managers, engineers, and auditors at 6 UTC Aerospace Systems manufacturing facilities in North America, Europe, and Asia Pacific. UTC Aerospace Systems business unit was closed during 2018 UTC merger with Collins Aerospace.• Drove supplier Zero Defect Plan (ZDP™) implementation.• Managed annual audits of 400 suppliers globally.• Improved supplier performance by influencing supplier executive leadership.• Built strong relationships with UTC Aerospace Systems global manufacturing site leadership teams.• Removed significant internal roadblocks to improve supplier quality performance. -
Global Quality ManagerEntrust Datacard Jun 2014 - Oct 2017Minneapolis, Mn, UsEntrust Datacard, based in suburban Minneapolis, Minnesota, is one of the largest global providers of security identification and card issuance solutions. Entrust Datacard is a private company with more than 2,000 employees, and approximately $600 million in FY17 annual revenue.Summary: Led a team of 11 quality engineers and technicians to improve enterprise quality in product development, manufacturing, and customer service.• Directly supervised operations quality engineers and technicians to support global manufacturing.• Established corporate operations strategies and objectives with executive leadership team.• Utilized data intelligence, such as RTY (Rolled Throughput Yield), SPC, and Statistical Sampling, to improve manufacturing performance.• Standardized manufacturing and inspection processes between China and US operations.• Successfully influenced design organization in DFM (Design for Manufacturability), and championed manufacturing engineer’s participation from early product design stage.• Led cross functional teams to resolve business critical issues. Used sound CAPA 8D discipline to ensure robust short and long term resolutions.• Improved supplier quality performance using Six Sigma problem solving skills and CAPA discipline. -
Principal Quality EngineerMedtronic Inc. Jul 2013 - Jun 2014Minneapolis, Mn, UsMedtronic, Inc. (NYSE: MDT), based in Dublin, Ireland, is the world's largest medical technology company, and it is a Forbes Global 200 company. Medtronic had 88,000 employees and $28.8 billion in FY16 revenue.Summary: Responsible for product quality and compliance at Medtronic’s most complex implantable medical device manufacturing facility. Developed a quality system to monitor product field performance in response to an FDA warning letter. Coached engineers in medical device cGMP and regulatory standards. Led Six Sigma projects to improve business processes. -
Sr. Quality EngineerMedtronic Inc. Aug 2010 - Jul 2013Minneapolis, Mn, Us -
Mechanical Engineer IiAdc Telecommunications Inc. Mar 2008 - Aug 2010Eden Prairie, Minnesota, UsADC was a $1 billion network infrastructure provider based in suburban Minneapolis, Minnesota. ADC was acquired by Tyco Electronics Ltd. (NYSE: TEL) in 2010. Summary: Led cross-functional teams during product commercialization. Provided culture change dynamics to instill discipline using Six Sigma tools and statistical techniques in product design and manufacturing. -
Applications EngineerBose Corporation Mar 2007 - Mar 2008Framingham, Massachusetts, UsBOSE Corp. is a private company based in Framingham, Massachusetts. ElectroForce Systems Group was a BOSE business unit that manufactured medical device testing instruments. Bose EFS Group was acquired by TA Instruments in 2015.Summary: Worked with customers to understand their requirements for medical device testing, and collaborated with product development teams to design and validate systems that met customer’s needs. -
Research AssitantUniversity Of South Carolina Aug 2004 - Mar 2007Columbia, Sc, UsUniversity of South Carolina is a public university with over 40,000 enrolled students.Summary: Performed scientific research related to congenital cardiac malfunctions. Conducted bio-medical research on various tissues including heart valve, skin, and bone. • Received full scholarship during the 2.5 year post graduate degree program -
Engineering InternBose Corporation May 2006 - Aug 2006Framingham, Massachusetts, UsBOSE Corp. is a private company based in Framingham, Massachusetts. ElectroForce Systems Group was a BOSE business unit that manufactured medical device testing instruments. Bose EFS Group was acquired by TA Instruments in 2015.Summary: Worked with customers to understand their requirements for medical device testing, and collaborated with product development teams to design and validate systems that met customer’s needs.
Jay Lu Skills
Jay Lu Education Details
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University Of South CarolinaMechanical Engineering
Frequently Asked Questions about Jay Lu
What company does Jay Lu work for?
Jay Lu works for Apex Tool Group, Llc
What is Jay Lu's role at the current company?
Jay Lu's current role is Director of Global Quality and Compliance.
What is Jay Lu's email address?
Jay Lu's email address is lu****@****ail.com
What schools did Jay Lu attend?
Jay Lu attended University Of South Carolina.
What skills is Jay Lu known for?
Jay Lu has skills like Six Sigma, Quality System, Continuous Improvement, Medical Devices, Iso 13485, Dmaic, Spc, Cross Functional Team Leadership, Product Development, Root Cause Analysis, Lean Manufacturing, Manufacturing.
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