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Director Of Regulatory Affairs Resumes

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1.
J Szteiter
Location: Toledo , OH 43613
... , coupled with solid retail experience in both banking and the security industries. I bring with me the "soft skills" necessary to develop strong teams and environments that foster open and honest communications; the ability to work well with others accomplishing common goals, the flexibility to 'juggle' and complete several tasks simultaneously, organized, detail orientated and motivated to go the 'extra mile' when necessary. Experience 2006 - Aerotech/Visteon , Toledo Molding & Die, Toledo, Ohio Contract Quality Engineer Manage the quality problems and issues that surface between the Toledo Molding and Die Company and the Toledo South Assembly Plant regarding completed Instrument Pa ...

97 hits
2.
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 ...

95 hits
3.
S Long
Location: Pittsburgh, PA 15237
... try 6 years in Policy/Procedure Development23 years in Fire and EMS/Rescue 6 years in Personnel Management12 years as Radiology Technology 6 years in Regulatory Agency Interactions12 years in Customer and Employee Training 4 years in Complaint Handling10 years in Clinical Applications 4 years in Adverse Event Reporting6 years in Program Management 4 years in Corrections/Remo vals/CAPA Professional ExperienceWolf Enterprises, LLC PresentPittsburg h, PA- Providing Quality Assurance and Regulatory Affairs consulting and expertise throughout product life cycle, for the medical device industry.General Electric Company ...

93 hits
4.
L Poggenburg
Location: Greenfield, WI 53220
... e-mail: louis.poggenburg @us.army.milCell : (815) 302 - 6549 ________________ ________________ ________________ ________________ ________________ ____________OBJE CTIVE: To obtain a challenging position as a Quality Professional where I can apply statistical techniques for cost reduction, regulatory compliance, and for continuous improvement..EDU CATION: BS Business Administration with Production/Opera tions Management concentration California State University, Hayward, CA 1999. EXPERIENCE: Allis-Roller LLC., Franklin, WI Aug 06-Apr 09 Quality Assurance ManagerResponsib le f ...

91 hits
5.
A Younce
Location: Superior, CO 80027
... ce evaluation along with problem identification, evaluation and resolution. Proven ability to affect change and collaborate across various disciplines in a large organization. Ability to effectively implement and manage large initiative projects. A collaborative leadership style focused on mentoring staff to achieve their full potential. PROFESSIONAL EXPERIENCE Ball Aerospace & Technologies Corp., Boulder, CO 1996-2007 A subsidiary of Ball Corporation, Ball Aerospace & Technologies Corp. employees over 3,000 employees and is an industry leader in advanced technology products for government and commercial customers. Their primary focus is on the design and manufacture of lar ...

89 hits
6.
E Dow
Location: Princeton Junction, NJ 08550
... leigh Healthcare is a manufacturer and distributor of medical devices. The product lines include DVT Prophylaxis Equipment, Patient Transport and Positioning equipment and Handheld Dopplers. I am responsible for all functions within the Quality and Regulatory areas that are regulated under 21 CFR - Part820 (Quality System), Part 803 (Medical Device Reporting), Part 806(Medical Device Corrections and Removals) and Part 821(Medical Device Tracking). I also serve as the Official Correspondent to the FDA. The manufacturing sites were certified to ISO 13485. There was a harmonized system and approach to quality with all Huntleigh Healthcare globally throughout the world.FDA ActivitiesHuntle ...

87 hits
7.
M Dufort
Location: Cheswick, PA 15024
... ervice skills with effective organizational and liaison relations. Direct experience with implementation of Federal, State and National Accreditation requirements.HIG HLIGHTS OF QUALIFICATIONS Management SkillsServes as the management representative for regulatory agency interface.Provid es leadership in interactions with collaborators supportive of operational excellence and methodologies to achieve success.Excellen t communicator with the ability to conceptualize between regulatory agencies, business segment personnel and executive management.Manag e operations & business processes for intra-company transfer of product lines, controlled substances and medical devices for domestically a ...

85 hits
8.
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 _____________ ...

83 hits
9.
E Marshall
Location: Vacaville, CA 95687
... intenance/repa ir organizations and manufacturers. Successfully lead teams in designing and improving audit and inspection processes to maximize quality, health and safety, and regulatory compliance across operations. Highly effective in conceptualizing and implementing training and ISO certification programs to deliver quality products and service performance. Strong expertise for managing operating budgets, quality documentation/pr ocesses, and teams supporting HSE and manufacturing operations. Eager to experience new challenges in a variety of industries. CORE LEADERSHIP COMPETENCIES• Project Management • Team Leadership & C ollaboration • Problem Resolution• ...

81 hits
10.
G Giles
Location: Loxahatchee, FL 33470
... plete revamping of ISO 9001:2000 System including major Operation Manual and Quality Manual rewrite. Implementation of Electro Static Discharge and NASA Hand Soldering Program. Turbo Combustor Technologies, Stuart, FL May 2004 - November 2004 Receiving Inspection · Performed chemical analysis, measurement and other material specification compliance testing. · Controlled certification paperwork and filing. Sermatech International, Boynton Beach, FL March 1998 - June 2003 Assistant Quality Manager, Tech, Etc... · Auditor for in-house, FAA and ISO Audits. · Calibration Technician (hand tools to Plasma Booths). · Records Administrator for Quality Records. · M ...

79 hits
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