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Title Quality Assurance Six Sigma
Target Location US-FL-Deerfield Beach
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Candidate's Name
Deerfield Beach, Florida, Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEQ/A Floor Inspector and Lead ImprovementSUMMARYQ/A Floor Inspector and Lead improvement, with more than 10 years of experience in Quality Assurance; Developing and Reviewing Standard Operation Procedures in order to: Upgrade Production, Cost Reduction; and Quality Assurance Implementation (under a Lean Six Sigma Process). All of this, in Pharmaceutical, Biotechnical, Vitamin, and Metal Mechanics Industries. Looking forward to work in a fast-paced environment Manufacture Plant. SKILLS AND ESSENTIAL FUNCTIONS:Utilize new lean technologies and methodologies to devise efficient systems that integrate workers, machines, materials, information and energy to eliminate resources waste under a Lean production process; Identifying Manufacturing Process could be automated; And Improve the Quality by implementing the famed Q/A Standard Operation Procedure (Poka-Yoke), based on 6 (six sigma) philosophy (99.7% not mistake). Main duties include, but are not limited to: Lead and participate in the improvement of quality and production using lean processes tools. Applicable to new development plant, new equipment installation; and automation production line, if Technical Economic Report throws short payback & high R.O.I. Provide statistical analysis reports evaluating the efficiency of current processes, procedures, equipment and associates, by using Time and Movement analysis by task, Standard production times (SPT) determination by products and its statistic support, Workers or team productivity factors determination. Develop and implement effective production flow layouts to include but not limited to: Physical cell/machine layout, Material presentation, and Material flow. Detect coaching needs and take actions in accordance with these needs in order to ensure compliance with quality standards, GMPs, FDA and SOPs; and implement the workshop courses customized for each case. Participation in validation/qualification manufacturing program (process, equipment, method); and capability analysis (Cp & Ck). Establish work Metric measurement programs and collect and analyze data: X & R Control Charts. Assists Change Review CBR with risk analysis management program (including Failure Model & Effect Analysis, FMEA). Help the Q/A Management to accomplish the main Objectives of Quality Assurance: Find out the root of the problems causing the deviations, by following the Corrective Action Preventive Action, CAPA System, Metric Statistical Trend Analysis; and prepare the Q/A S.O.P., including the HOW TO DO THE JOB section, to avoid the repetition of mistakes. A special mechanism should be designed in order to let the system autocorrect the mistake by itself. The goal is to ensure quality level of 6 by using poka-yoke procedure (attached). WORK EXPERIENCENatures Bounty, NBTY: Q/A Floor Inspector. Boca de Raton, Since May 24, 2019 until Sep 30, 2019 Temporary assignment. Developing the Q/A Standard Operation Procedure for registering the Retainer products under a quality level of 6 by using poka-yoke and implement the process. In this project a saving of $ 300.000 in the Sink Cost, were achieved by reducing the operation time to the to the half; and the Quality of the Register was increased to 6 sigma, because an autocorrect feature developed in excel for the process (copy and paste & Sort data analysis). On the other hand, a potential future saving cost of $ 3 million was identified by assuming the retainer time for finished goods in 2 years after expiration date, as compared with the FDA regulation and requirements. Developed the Procedure, for implementing the Q/A SOPs with the How to do the Job section to ensure the quality of the manufacturing process under a Lean Six Sigma environment. Developed the S.O.P, Work Brake Down Structure (WBS); for a new TEST ROOM, with positive pressure air flow for the sampling of row material. Developed the S.O.P. (WBS) to store Temperature Sensitive and explosive Raw Materials in appropriate place as per storage conditions. Define the procedure for ABC cost classification for the Inventory. At the first level, in order to identify the 20 % of the raw material with the 80% of the total value. As a second level, the rotation Inventory ABC classification; its the 20% of the previous products selected with the 80% of movement or rotation. Developed Optimum Level of Inventory procedure & control System (Security Levels, S.L.) for raw material: Storage space was guaranteed by using a MonteCarlo Simulation program; Everything, for assuring the 6 (six sigma) quality level (99.7% no fault). See procedure attached. HOME and COMMERCIAL COMPLEX DEVELOPMENT 2014 to 2019  Project Coordinator and Q/A Inversiones Urupagua C.A.; In charge of developing multi-family housing; and commercial complexes; with Reinforce Concrete Structure and concrete brick walls; Main activity was related to Q/A for the customer. Metric Analysis as: X&R Control Charts, Equipment, Process & Personnel Validation, Corrective and Predictive Actions (CAPA), Six-Sigma (6 ) Quality Risk Analysis (Trends, Covariances, FMEA) as well as; Statistical Capabilities Analysis (Cp & Ck); were performed for concrete compressive strength test and cone test. PATHFINDER LLCs Asset Division, Cherry Hill, N.J. Associated consultant 2006 - 2014 Associated to Consulting Company assisting to ECOPETROL Colombia and several Manufacturing companies in the area of Petrochemical, Refinery and Pharmaceutical; main duties were: Project review (Cost & Schedule) by using the concept of Value Engineering in Fels 0 to 5. Determination of the Project Definition Rating Index (P.D.R.I.) for financial approval in Fels 3 stage. Several Standard Operation Procedures, for Q/A and manufacturing production upgrade. Corrective and Predictive Actions (CAPA), Six-Sigma (6 ) Quality Risk Analysis (Trends, Covariances, FMEA) were performed.CENTRAL UNIVERSITY OF VENEZUELA: 1972-2014. Head of the Department of Production Management (External Consulting Services) of the FACULTY OF PHARMACY. For 11 years. Advising and giving Consulting Services to the Venezuelan Pharmaceutical Industry, in Q/A S.O.P., Production Line Automation, Bottle neck solution and equipment installation and Validation. Following are the main duties performed: Quality Assurance Services: Find out the root of the problems when the testing procedure detected significant quality Deviations, according to the product specification stated in The Standard Operation Procedures (SOPs) of the company, Good Manufacturing Practices (cGMPs ); and Ministerio de Sanidad (equivalent to FDA in USA) Conformed with the alumni of UCV Pharmacy Faculty, a data base with more than 3600 S.O.P., up today and approved for many industries: Pharmaceutical, Biotech and Vitamin manufacturing plants, in Venezuela and at international level. See attached Procedure for doing S.O.P. starting with outstanding models. This data base linked to the associated Pathfinder Network gives to me a real comparative advantage. EDUCATION: INDUSTRIAL ENGINNERING, MSc. - Louisiana State University - Baton Rouge La, GPA3.32 INDUSTRIAL MAINTENANCE (Course and training for 1 Year.) ONUDI, I.R.I. - Rome, Italy. LANGUAGES and computerized skills: Fluent in Spanish, Italian and English Proficient with microcomputers: Excel 2007 (Macros programming), Word, Project from Microsoft (Pert-CPM including Cost and Resource Loading). Risk Analysis (MonteCarlo Capacity Simulation, Time Series Decomposition for forecasting purposes; & Econometric Models for investment purposes). Expert in Reviewing Material Planning Requirement Programs. Q/A Software: Corrective and Preventive Actions, CAPA; carry on Excel (macros) and Primavera (pert CPM) use as QMS. However, adaptable to any software used by the client such as: QMS, Management Master Control, TrackVia, Qualio, IQS, as well as anothers restrictive Software. The experience taught me, to export information from then and use Excel for Quality Metrics Statistical Analysis (X & R Control Charts including Covariance Analysis required by 6 sigma Risk Analysis), Risk assessment FMEA (Failure Model & Effect Analysis),. CITIZENSHIP: U.S. Citizen.PROFESSIONAL REFERENCES1:Karl Mazeika  PDVSA, Vice President  Ph. +1 585 748 6260 Karl.Mazeika@vetragroup.com Eurpides Romero  Inelectra Miami, Manager  Ph. +1 786-246-5709 EMAIL AVAILABLE Franks Dozsa PDVSA Manager SA  Ph. +58 412 229 0662 EMAIL AVAILABLE Guillermo Rodriguez -Pegasus International Inc  Ph. +1 281 235 3321, +1 281 670 7730 EMAIL AVAILABLE Paul Collins  Pathfinder L.L.C Vice-President  Ph. +1 281 8518297 1Please call, when the employer is ready for contracting. Those persons are really very busy.

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