Director Of Regulatory Affairs Resumes in Tennessee
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1.
S Gazaway Location: Knoxville, TN 37934 ... of leading-edge solutions driving record-setting accuracy. Able to build solid relationships with strategic partners as well as consensus across multiple organizational levels in support of cost, profit and customer service.SUMMARY of QUALIFICATIONS•I SO 9000:2000 RAB Certified Lead Auditor•ISO 14001 OSHA Auditor, TS 16949 Auditor•Master of Science Degree in Analytical Chemistry•Certif ied Lean Sigma- Villanova University•Exten sive knowledge and experience of polymer chemistry and manufacturing: emulsions, adhesives, plastics •Developed site paperless document and records control system including Quality Manual(s)•Author of numerous procedures, test methods and work instructions.•Au tho ...
97 hits
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A Clark Location: Hendersonville, TN 37075 ... e established strategic plans, developed systems and operational overhauls that were instrumental for new product design and roll-out resulting in performance improved and profitability accelerated. Leadership includes strategic business planning, operations, risk management, negotiations, equipment modification, new product design, testing, quality control and facility utilization. Certified Quality Technician (CQT) and a Six Sigma Green Belt.Selected AccomplishmentsS pearheaded and directed the acquisition of UL classification for 2 medical devices.Prepared Quality Manual for FDA 510(k) Certification and participated in 3 FDA audits that resulted in zero non-conformances .Constructed an ...
95 hits
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P Guy Location: Brentwood, TN 37027 ... (615) 416 - 5210 (Cell) PROFILE ACCOMPLISHED ENGINEER / PRODUCT ENGINEER / MANAGER / QA / QC to world’s leading manufacturers offering technical knowledge, leadership ability, analytical expertise, and refined communication skills. Conscious ability to troubleshoot and solve problems with attention to detail. Significant career accomplishments include: - Reduced OSHA recordable accidents by 75% within 2 years. - Received 2 National Quality Awards - Increased productivity by 5% at production center within 8-month period by coordinating training program ...
93 hits
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C Parker Location: Smyrna, TN 37167 ... d, pharmaceutical, and medical device manufacturing processes to determine FDA compliance. Result: Prevented manufacturing loss time, product recalls, and legal exposure. Analyzed food and over the counter pharmaceutical, health and beauty aids to ensure public safety. Result: Ensured safe delivery of products to the public and compliance with FDA regulations.Iden tified non-compliant processes and procedures during inspections to determine FDA compliance. Result: Recommended corrective actions and persuaded companies to comply.Troublesh ot the de-ionized water treatment system to determine where contamination occurred. Result: Reduced cost by preventing contaminated products being releas ...
91 hits
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K Greer Location: Goodlettsville, TN 37072 ... nting quality control systems in ateam-based environment, excellent interpersonal skills, managing projects and workingclosely with production personnel to implement new procedures. Constant interaction with Plant Management to provide Technical assistance withIngredients, Finished Products and Procedures.Maint ain the HACCP Program and Documentation to assure USDA/FDA Compliance.EMPLO YMENTQuality Assurance, Asst. Manager, T. Marzetti, Horse Cave, KY June 2009 - PresentHigh quality manufacturer of salad dressings, coleslaw dressings, mustards, marinades andchocolate sauces.Monitor conformance to customer chemical and sensory standards. Insure conformance to allregulatory standards. P ...
89 hits
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P Hopkins Location: Nashville, TN 37221 ... Quality Manager Trinity Marine Products, Inc. Introduced internal quality auditing plan for process improvement. Established company Quality Steering Committee. Redesigned Material Planning Reporting System. Established Top Focus Plan and Quality Plan introduction. Introduced Quality Wall Index for metrics improvements. General Motors Supplier Quality Representative Saturn Division - Powertrain section. Managed several GM major supplier assembly line disruptions; Leading root cause investigation, containment policies, controlled shipping policies, reimbursement data collection. Employed corporation major disruption management techniques and root cause analysis for LUK clutches and torque ...
87 hits
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G JANSEN Location: Franklin, TN 37064 ... vision & tactical implementation skills to: Accelerate growth and increase revenue in corporate operations ~ revitalize poor performing locations. Maximize P&L performance through strategic planning, process & product improvements. Lead significant improvements in Quality Management in manufacturing, technology, & supply chain. Develop mentor & lead talented & cohesive senior teams with integrity and enthusiasm. PROFESSIONAL EXPERIENCE CP Kelco-A JM Huber Company $2.0 Billion Company with operations in 18 Countries-CP Kelco is a leading Global producer of specialty hydrocolloids with 9 plants in North America, Europe, Asia and Latin America. Products are ...
85 hits
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G Biles Location: Clarksville, TN 37043 ... rofessional experience. Engaged in strategic and tactical program management, manufacturing, supplier management and quality assurance to drive business plans and objectives to meet customer success. Recognized by senior leadership team as highly responsible, results oriented and strong in interpersonal skills. Dedicated professional with both domestic and international experience in designing, implementing and monitoring a broad range of manufacturing activities. PROFESSIONAL SKILLS: ? Corrective Action Assessment? SAP ? FMEA’s ? IS/QS 9000? Root Cause Analysis? New Product Introductions ? Six Sigma Black Belt? Data Collection? Kazian/Lean Manufacturing ? Statistical Process Contro ...
83 hits
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S Taylor Location: Vonore, TN 37885 ... th foreign and domestic that utilizes my skills in Lean Manufacturing, Six Sigma, Quality, Purchasing, Engineering, Auditing, and that has opportunities for advancement. EDUCATION: Bachelor of Science in Mechanical Engineering USN/ Vernell University, New York 1980 - 1984 Minor in Marine Design CERTIFICATIONS: Lead Assessor in ISO9000-2000/200 8, TS16949, ISO14000, ISO13485. SKILLS AND ACHIEVEMENTS: Leadership and Interpersonal: Led successful cross-functional teams to resolve issues by contributing problem-solving expertise, developing team strengths, and providing focus and guidance. Technology : Key member of Product Development/Purc hasing team in selecting materials for Seats, Rim, ...
81 hits
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R Foster Location: Oak Ridge, TN 37830 ... elding, glazing, interior and safety systems) primarily in the automotive industry.Strengt hs include the ability to set & achieve department and company goals; work under pressure to meet deadlines, develop & manage a budget, and work with associates at all levels of an organization to achieve success. Experience in the following includes:Six Sigma (Black Belt)Continuous Improvement (Kaizen)Product DevelopmentProgr am LaunchesISO-TS16 949, QS9000APQP (AIAG & SQAM)PROFESSIONA L EXPERIENCEEast Tennessee Earth Alliance - Oak Ridge, TN Oct. 2008 - Pres.Co-Director (Non Profit)Worked to coordinate Earth Day 2009 in Oak Ridge, TN. This was the fourth annual effort ...
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