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Manager Of Regulatory Affairs Resumes

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1.
M Hinck
Location: Huntington Beach, CA 92648
... omer Returns from 105,000 DPPM to 950 DPPM in 2007 for both Honeywell and Hamilton Sundstrand by implementing Lean Six Sigma tools and methodologies. -Reduced scrap costs by 75% ($1.5 million) in the Actuation Business Unit by refining the reporting structure relating real “SCRAP COSTS”.-Reduced supplier rework costs by 37% ($850K) by teaming with key suppliers to design out manufacturing variances in their machine processes.- Six (6) Sigma Black Belt Certification by American Society of Quality (ASQ) - Implemented Design for Manufacturing process whereby variation was reduced by 50 % ($1.62K) in the actuation gimbal assembly cell. Used Process FMEA tools to assign risk priority values to as ...

97 hits
2.
V Collins
Location: Jacksonville, NY 14854
... d revenue contributor, with cross-department al abilities, who combines solid grounding in computing technologies with proven engineering and management consulting/opera tional capabilities. Excellent written, verbal, and presentation skills. Global Experience: Direct onsite involvement for extended periods in Singapore, Taiwan, Hong Kong, Japan, United Kingdom, Switzerland, Germany, Puerto Rico, Pacific Islands, Philippines, Israel, and Saudi Arabia. Many of these projects were cross-boundary assignments for hardware/softwar e and for commercial/Aeros pace entities (Contract and Full time positions). Leadership, team and individual contributor with participation in the development, ...

95 hits
3.
S Chan
Location: Atlanta, GA 30339
... of Technology, Atlanta, Georgia ADDITIONAL COURSEWORK Biochemical EngineeringProce ss Safety Engineering BiochemistryMicr oelectronic Process Engineering Microbiology EXPERIENCE Texas A&M University, College Station, TX Graduate Research Assistant, Sep 97 ¡V Aug 02 ·Thermophil ic anaerobic fermentation of waste biomass for producing acetic acid with mathematical modeling Conducted fermentation experiments using waste biomass as substract, such as synthetic municipal solid waste and corn stover, and mixed microorganisms as inocula collected from variety of sources, such as rumen fluid, swamps. Explored the possibility and solved problems encountered from thermophilic conditions fo ...

93 hits
4.
J Omilion
Location: Rochester Hills, MI 48307
... 28 Cell: (248) 495-7587 Human Resources Specialist: As the quality manager for Orchid Bio-Coat orthopedic solutions, I have spent the last few years working in the health care area. I worked aggressively to improve customer-client relations as well as improve the quality of the product and the efficiency of the organization. Strong customer contact experience. I have been involved with Kaizen events, process and continuous improvement projects. I was also responsible for internal audits and 2nd party supplier audits as the auditee. My time at Orchid Bio-Coat allowed me to become intimate with the workings of orthopedics especially the intricate mechanisms of joint replacement. With previo ...

91 hits
5.
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 ...

89 hits
6.
J Randolph
Location: Easton, CT 06612
... nely deploy cost effective process and systems continuous improvement and instill methodology to sustain performance. Excel at instructing and inspiring high performance teams while advocating process improvement across the organization. Effective user of DMAIC and DFSS approaches. Analytical, insightful, and highly goal oriented. Experience 454 LIFE SCIENCES, INC., Branford, CT2007 - Present Director - Quality Assurance Conducted multiple projects for product reliability improvements and company roadmap to cGMP. Initiated CAPA transition to a validated and Part 11 compliant workflow tracking system. Reduced field failure rate 50% deploying DOE tactics. IKONISYS, INC., New Haven, C ...

87 hits
7.
J Henderson
Location: Redondo Beach, CA 90277
... s manufacturers. From concept to delivery consistently exceeding customer expectations of toys, hard lines, soft lines, textiles, electronics, art materials, stationery, apparel, confections, children's, consumer and juvenile products for many of the world's most recognizable consumer brands.Inspectio n and Testing: 5+years domestic and foreign consumer laboratory testing experience assessing and implementing test programs, conducting design concept reviews, and performing physical and mechanical testing according to regulatory, industry and retail standards Factory and Product Audits: Executed over 100 social compliance audits in 20 countries according to the guidelines of Current Good Man ...

85 hits
8.
G Horacek
Location: Medina, OH 44256
... ivated with strong multi-level communications, specializing in multi-tasking, root cause analysis, problem solving and situational leadership.Achie vementsMaintaine d ISO systems for 4 separate manufacturing facilities with a total of 350 employees across 3 shifts 7days a week - including a TS-16949 system for a satellite company in another state.Manager/Su pervisor for 2 Quality Technicians and 5 Inspectors in 4 Plants.Implement ed and sustained real-time / networked SPC that significantly reduced scrap and rework resources. Integrated ISO-9001 and ISO-14001 systems that increased effectiveness and reduced 3rd party audit time. Achieved a no OFI or CAR surveillance audit 1st half 2007.Imple ...

83 hits
9.
M Arganosa
Location: North Hills, CA 91343
... Quality Control, Research and Development, Procurement, and production of processed food. Sound knowledge of sales projection, budgets, expense control and standardized procedures designed for stable operations and bottom line profits. Expertise in staffing training, motivation and evaluation of personnel to assure adherence to quality service and customer satisfaction. In depth knowledge on reformulation of product ingredients and simplification of process to improve quality and production standards. Work Experience 2006 – Present Southgate Foods Southgate , Ca Quality Control Manager Developed and implemented the HACCP program and the quality monitoring reports to meet the USDA requir ...

81 hits
10.
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 ...

79 hits
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