D Nelson Location: Laguna Niguel, CA 92677 ... perience seeking employment with a company that values strength in core beliefs and commitment to excellence. Management expertise in quality systems with proven success in leading company focused teams in compliance and certification to multiple quality standards (ISO9001:2008, ISO13485, AS9100:2003, and TS16949). Hands-on, collaborative leader with expertise in facilitating lean manufacturing operations directed at improved product quality and reliability. Proven experience in managing programs from inception through final delivery to end user Customers on time and within budget. Thoughtful leader with effective team building skills and decisive problem-solving capabilities focused on ...
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W Saunders Location: Stockton, CA 95207 ... gn, Development and Delivery, of effective and efficient Quality Systems and Employee Development Programs. I have a proven track record for "results oriented" and Compliance Based, Quality Systems and Training programs that are designed to improve our team in multiple areas. I have the skills required to provide leadership in the effective delivery of training in the areas of Regulatory Compliance, CGMP, CGCP, CGLP, Technical Training, Software Applications and Employee Development Training. I am fully versed in FDA Regulatory Compliance Systems for Biotech, Pharmaceutical, and Medical Devices. I have a strong Quality Systems background with emphasis in, QSR Compliance Trainin ...
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W Crawford Location: Hollister, CA 95023 ... SUMMARYQuality Program Lead Manager experienced in the System Development and DemonstrationPha se of the Army Future Combat System (FCS) Manned Ground Vehicle (MGV) Program withan emphasis on system design, development, integration and delivery of 5 functional vehicle prototypes to the US Army. Lead TQM, QMS, and ISO9000/AS9100 procedure and requirementimple mentation between Boeing (LSI), BAE Systems, the Army, DCMA, and other One Team Partners. Extensive Engineering experience in the design, development, and manufacture of high performance hard disk drives for enterprise-class computer systems. Lead experimental designand qualification engineer for customer acceptance an ...
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D Cooper Location: Bakersfield, CA 93307 ... on as a CWI (#07080631) and a Level II MT & PT certification. I specialize in the ASME piping and vessel construction code and have worked with the AWS & API codes as well. I pride myself on having a very good work ethic and being dependable, hard working, and detail oriented. I feel that with my knowledge and experience that I would be an asset to your company and its final product.Educatio n Surprise Valley High School--1973 Graduate US Air Force (1973 to 1976) MOS Security/Law Enforcement-Hono rable Discharged at the rank of E4. Modesto Junior College (1976) Machine shop/electronics Bakersfield College (2004) Auto CAD Work Experience1976-1 978 Custom Aire; Turlock, CA H ...
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D Reggie Location: Altadena, CA 91001 ... Production Experience: Direct plant in production, processing and packaging.• Technical Experience: R&D Product Development, Laboratory Management,Senso ry Evaluation, QA/Laboratory Technician• Regulatory Experience: Ensures compliance to required directives.EDUCA TION University of Redlands, Redlands, CA M.B.A. 10/08 -10/10 Cal Poly Pomona University, Pomona, CA B.S., Biology (Zoology Minor) 09/96 -09/03 EXPERIENCE Affinity Flavors, Corona, CA 10/06-Present Quality Assur ...
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T Stephens Location: Livermore, CA 94551 ... fications (Initiator/Evalu ator; Investigator; Resolution Planner and Approver) and am currently in training with the QRB for CAPA approvals.Develo ped new manufacturing process for Molecular Diagnostics Assay Standards that prevented assay drift and presented poster on process at Abbott Technical ExchangeEstablis hed entire line of Manufacturing and Testing documents for new platform assays Established lab at new vendor and trained personnel for testing of the antigen on our platformSuccessf ully facilitated root cause investigations into multiple product failures and executed associated CAPA'sAverted off market scenario for Total PSA AssayFacilitated the Quality System Refresher course at ...
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W Koehler Location: Riverside, CA 92507 ... y Assurance SupervisorHired to work the third shift as existing personnel needed guidance on proper AQL methods.Ater two months worked half of second and third shifts to include giving guidance to 2nd shift. I am now working second shift with an overlap of third, writing SOP's for the Label room to bring into compliance for the new FDA CFR rules.I review all master formulas to insure the ingredients and amounts will meet the customers label claim.I am currently in charge of 5 QA Inspectors in production, 1 QA in Packaging,2 QA in the label room and 4 QA and 1 Lead QA on third shift. I am currently rewriting several SOP's to meet the new CFR rules and developing the cleaning validation of pro ...
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J Pulley Location: Wildomar, CA 92595 ... ce in Class II and Class III medical and biomedical devices. Designed and implemented progressive profitable solutions to products’ design, manufacturing processes and compliance issues with Federal/State and international agencies at both a small 20 Million Dollar/year and a Fortune 100 medical device manufacturing company. Areas of expertise include: FDA/EU Regulations, cGMP, QSR, ISO9001, ISO 13485, ISO 14971, ISO 10993-1, EN 46001, MDD Compliance and design of Technical Files, 93/42 EEC, 510(k) submissions, MDR submissions Quality Strategic Planning Quality Control and Assurance Management Analytical Laboratory Instrumentation Material and Process Engineering Troubleshooti ...
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T Earl Location: Santa Maria, CA 93454 ... J¨I¨T Manufacturing, Inc. Paso Robles, CA 3/2008 to Present Engineering & Quality Manager Directs quality program designed to ensure continuous production of products consistent with established standards. Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product. Directs engineering for new products design, manufacturing efficiency and continues product improvement. Inter face with representatives of ISO 9001:2000 certification, customer, and suppler vendors to obtain information related to quality, capacity and performance ratings. ...
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K Otsuka Location: San Mateo, CA 94403 ... ision, Inc., Hayward, CA Quality Engineering Manager (February 1997 - Present)Manufact urer of reclaimed silicon test wafers for the semiconductor industryEstablis hed Quality system and achieved ISO 9001 CertificationPer sonally programmed Work-In-Process (WIP) tracking system using Microsoft Access database, which covers,Product Specification and Process RequirementReal- time inventory, production yield and defect ratio Internal and External document control (Procedures, ECN/TECN and customer specifications)S PC programDownload inspection data from equipments and auto generate Product CertificateIncom e procurement quality controlMachine downtime and PM scheduleWorked with IT department t ...
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