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Manager Of Regulatory Affairs Resumes in Texas

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1.
V Brown
Location: League City, TX 77573
... iven, process-oriented accomplished professional with over 15 years of senior leadership experience in Quality Management, Regulatory Compliance, Product/Process Development, and Project Management in U.S. and global markets serving the biotechnology, pharmaceutical, chemicals, fine chemicals and healthcare industries. Possess strong strategic and tactical background in manufacturing and production environments, holding P&L responsibility for multimillion-dol lar operations; key product development and launch initiatives and organizational transitions- mergers and acquisitions. Expert in recognized compliance standards - cGMP, ISO 9000 series, ANSI, ASTM, HAACP and USP Verified to name ...

97 hits
2.
I Thor
Location: New Caney, TX 77357
... rformance improvement projectsEffectiv e leader of multidisciplinar y teams.Ability to develop and achieve goals.Extensive knowledge and successful implementation of customer service programs.Ability to streamline process to increase effectiveness and reduce costs. Effective mediator for conflict resolution.Abili ty to establish positive working relationships with physicians and staff.Ability to aggregate and analyze data to identify opportunities to improve services and reduce riskResolution of patient/family complaints and grievance.Succes sful implementation of medical staff peer review programs. LICENSE and CERTIFICATIONSAc tive Registered Nurse (Texas)2008 and current Healthcare Accr ...

95 hits
3.
H Hutto
Location: Fort Worth , TX 76112
... elf-motivated, decisive leader and innovative thinker in pursuit of new methods for practical applications of industry specific standards. Known for hands on expertise. Committed to cost reduction and creative issue resolution. Certified Lead Auditor with specific reference to FDA by RABQSA.COMPETENC IES AND SKILLS Understanding of standards: ISO9000, 9001, 13485, AS9100, AS9102, TS16949, API, ASME Sec. I, II, III, CFR 10, 21, 49 & 50 Knowledge and use of quality tools: lean manufacturing, TQM, CAR, CAPA, FAIR, FMEA, IQAP, PPAP, 9Ds, 5 Why, 5 S, SPC, Strong supplier management experience including supplier development and qualification/ce rtification process, measurement ...

93 hits
4.
W Zollicoffer
Location: Frisco, TX 75035
... ck record in communication, technical writing and auditing skills combined with a reliable and dependable work ethic would make a positive contribution to any organization.PRO FESSIONAL EXPERIENCEDRAGON WIND, LLC JULY, 2009-PRESENTDire ctor of QualityWrite Quality Manuals, Policies and ProceduresEstabl ish Quality StandardsQualify Welding ProceduresTrain Personnel to requirements and manufacturing techniquesCustom er liaison on matters related to qualityTRINITY INDUSTRIES, INC., DALLAS, TX 2006-JULY, 2009Manager of Supplier Quality and Internal AuditsManager of the Internal Quality Audit Program for 41 manufacturing facilities including a staff of three other full-time Quality and Product ...

91 hits
5.
G Sunderland
Location: Georgetown, TX 78626
... nterprise multi-billion $ products in the financial industry. I used the following tools: Peoplesoft, JAVA, 508 compliance, AccVerify, SaaS, JAWS, Top, Perfmon, VMSTAT, IOSTAT, Sharepoint & Rational Tool Suite. I have an MBI clearance for the contract. I set up the QA group, ITIL, ORT, CMMI process creation, test planning, automation, integration testing, tools evaluations, proposals, strategy, AJAX, UML, OOD, test cases, test data creation, business requirements analysis, test execution & defect root cause analysis. We used VM technology, Mainframe, SQL, LINUX, Vista, Office 2007, Oracle & UNIX servers to support testing and development efforts.2006-200 7 Northrop USAFTest ...

89 hits
6.
N Carlsen
Location: Georgetown, TX 78628
... root cause and initiate CLCA problem solving solutions with immediate results via out-of-the-box thinking and leadership. Recognized as an energetic and focused results oriented leader, communicator, and innovator with superior business acumen. • Quality System Development, Training, and Management • 6-Sigma Problem Solving • 5S's and Lean Manufacturing • Auditing • Supplier Quality Management • Budgetary Control • Goal Setting • Data Collection and Reporting • Customer Quality Project Management • New Product Qualification and Release to Production • Presentations • Employee Selection and Development • Leadership • Continual Improvement • Contract Manufacturer Management _____________ ...

87 hits
7.
L Nunez
Location: Mission, TX 78572
... 01/TS 16949 Process Auditing. Certified Six Sigma Green Belt. Extensive hands-on experience as an Engineer and Project Manager. Lean Manufacturing Methodology, and Quality Management Systems Implementation in a production environment. Strong technical skills, from design to implementation of electronic instrumentation. Outstanding record of success in overseeing testing installations and start-ups. Bilingual (English-Spanish ). Strong Pro-Active Problem Solving Skills. Very strong communcation, negotiation, and presentational skills in a Production Enviornment. Professional ExperienceAlps Automotive / Total EMS (Electronics Mfg.) 2009 Supplier Quality Engineer/Process Quality Management ...

85 hits
8.
R Edelen
Location: Mckinney, TX 75069
... ions experience in most industry sectorsCreative problem solver and excellent communicator with executive presence and business ethicsCapable and focused professional with a track record of establishing solid working relationshipsSuc cessful change agent with experience in building teams and risk management programsSix Sigma and Process Mapping trainingPROFESSI ONAL EXPERIENCEDiebol d/Premier Election Solutions 2004 - 2009 Director, Quality Management Systems and QAA global company with $4 billion in revenue serving the ATM, Security and Election industry with products and services that help banks and election officials deliver superior service to their customers.Other dut ...

83 hits
9.
J Francis
Location: Lewisville, TX 75077
... ability to follow projects to completion. Strong interpersonal skills to excel independently or on a team.Career ObjectiveTo use my management skills and experience for the benefit of a company that rewards excellence and stimulates professional growth.Career HistoryTurbine Engine Resources, Ltd. May 2004 to August 2009Carrollton, TexasDirector, Quality Assurance and Operations responsibilities and achievements included:Managed department performance through motivation, monitoring and coaching. Monitored employee attendance, productivity, and counseled employees as needed.Developed , implemented, and maintained quality documents, programs, and procedures.Devel oped, implemente ...

81 hits
10.
S Sittner
Location: Houston, TX 77089
... (CELL) (832) 524-6168Address: S. Scott Sittner23969 N.E. State Route 3Suite GPMB #252Belfair, Washington 98528-9699U.S.A. Email: scott_sittner@ya hoo.com Qualifications29 Years Experience as a proven, "Hands On", Project Manager, Senior Quality Assurance-Contro l Manager, ASME Certified ASME NQA-1 Lead Auditor (Current, Active Auditor with 10 Previous, Separate Certifications) Certified Audit Trainer, Process Improvement Professional.Sen ior Management level experience in directing and controlling complicated National and International Projects of various types, PWR and BWR Commercial Nuclear, Petroleum, Construction, Manufacturing, Aerospace, Federal Grant and Environmental Pro ...

79 hits
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