Director Of Regulatory Affairs Resumes in Pennsylvania
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1.
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 ...
97 hits
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T Hahn Location: Gibsonia, PA 15044 ... . Air Pollution Control for Coal Burning Power Plants Direct Responsibilities include the development of an Integrated Management System. The system centered on an ISO 9001:2008 certified Quality Management System with the integration of the ISO 14001:2004 Environment Management Standard and the OHSAS 18001:2007 Health and Safety Guideline. Lead Supplier Quality Engineer for rotating mechanical equipment. Induction Motors 2500 HP plus, Oxidation blowers, ID Fans, Slurry Pumps, Vacuum Belt Filters PROJECT QUALITY MANAGER Aquatech International Corporation, Canonsburg, PA March 2006 to October 2007Responsibili ties include the implementation of an I ...
95 hits
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H Bittner Location: Pittsburgh, PA 15243 ... als and objectives.Educa tion: Lafayette College 1969-1977 Easton, PA B.S. Mechanical Engineering Honors: Pi Tau Sigma – Mechanical Engineering Honor Society Lafayette College 1969-1977 Easton, PA B.A. Mathematics University of Pittsburgh 1978 - 1982 Pittsburgh, PA M.S. Mechanical Engineering Courses Robert Morris College 1982-1985 Moon Township, PA M.B.A. CoursesExperienc e: Bucyrus Inc. September, 2006 - PresentHouston, PA Quality Leader Responsible for initiation, development, implemetation and maintenance of an ANSI/ASQC 9001 system - audited and approved by DNV. The confines of the system included procedures, SOPs and Process Approvals. Internal and External Audits wer ...
93 hits
4.
C Oconnell Location: Warminster, PA 18974 ... diverse rigid paper and transparent plastic box plants on the East Coast, along with a state-of-the-art corrugated facility. Quality Manager · Implement and Maintain: o Calibration System o Corrective and Preventive Action System o Training Program o Departmental Procedures (including testing) o Internal Audits o External Supplier Audits · Responsible for the overall functions of the quality department and personnel. · Manage the cost of quality and communicate the health of the Quality Management System, on a weekly basis to management, and recommend areas of improvement. · Respond formally to customer complaints. Brooks Instrument - Hatfield, PA February 200 ...
91 hits
5.
C Chilcott Location: York Haven, PA 17370 ... nieec@comcast .net PROFILESmall Business Development and Management Project Management Product and Market Research Brand Maintenance Cross-Functional Team Management Dental and OTC Drug Product Development and Management PROFESSIONAL EXPERIENCEDental Technologies, Inc Chicago, ILQA and Regulatory Manager 12/08 - 09/09Directed ISO 9001 Quality Management System.Managemen t Representative for the Quality Management System.Provided inspection criteria throughout production cycle.Managed personnel involved with inspecting and testing final product to insure continuous control over products.Worked with vendors to ensure quality of purchased parts.Managed document ...
89 hits
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M Crookshank Location: Cranberry Twp, PA 16066 ... ocess Management * Six Sigma *Supply Chain Management * Lean Manufacturing * Management System Assessments * Statistics______ ________________ ________________ ________________ ________________ ______________Se lf-Motivated Quality Assurance professional with 20 years of experience in Quality System implementation, improvement and assessments. Consulted with the NASA Langley Research Center in implementing and successfully certifying their quality system, managed the Penn State University quality system for the NASA SWIFT Satellite program which successfully launched in 2004 and continues to exceed expectations today. Currently serve as Strategic Account Manager and corporate liaison with ...
87 hits
7.
J Boruta Location: Perkasie, PA 18944 ... er management. Structures effective programs to adhere to the policies and procedures of an organization as well as outside agencies. Consolidates internal processes to capture substantive cost savings and enable superior utilization of resources. Serves as an integral resource for efficiency and customer satisfaction during periods of transition. Achieves value-added goals on time and within budget.A self motivated and enthusiastic leader consistently recognized for exceeding expectations. Applies a results-oriented work ethic to engage and resolve obstacles. Undertakes additional responsibilities , leading projects to successful conclusions. A skillful communicator who builds and ma ...
85 hits
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R Andrian Location: Lansdale, PA 19446 ... cturing experience. An efficient manager with more than 5 years experience, controlling budgets of more than $800,000 yearly. MANAGER EXPERIENCE -coordinated the development of the Training Program, the Management Review, Internal Audit Program, continual improvement program, corrective and preventive action for suppliers, customers and internal processes, the writing and issuance of all the documentation, implementation of new processes, in view of certifying the company to the ISO 9001:2000 standard. - developed and managed a viable Quality Management System from non-existence, in interval of the year 2004, and certified the division of a medium-sized private corporation to the ISO 9001:2 ...
83 hits
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S Stutzman Location: Salunga, PA 17538 ... n a project, part-time, or full-time basis. PROFESSIONAL EXPERIENCE: Proprietorship ( Consultant-Steve Stutzman-Quality Engineering Services) 03/07- Present Design, Develop and Implement economical consulting services using ASQ Quality Tools to provide continual improvement services to organizations. Participated in self-study and classroom study groups for self-improvement , business development, services/product design/developme nt, and entrepreneurial endeavors. Fidelity Technologies Corporation, Reading, PA 1996-2007 Quality Manager/Senior Quality Engineer 08/02-02/07 Manage a registrar certified Quality Management System (QMS) to the requirements of ISO 9001:2000, Management ...
81 hits
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D Borgnis Location: West Chester, PA 19382 ... ch Organization (CRO) environment. Over 20 years of diverse and progressively responsible positions within the Quality Assurance, Regulatory Affairs and Operations both in the Pharmaceutical and CRO industry. Performed functions ranging from Project Management, Data Management, Quality Assurance and Regulatory Affairs. Managed groups as small as two people and up to thirteen people. EXPERIENCE Pierrel Research USA (formerly part of Encorium USA) Wayne, PA 1996 to 2010Director, QC and Documentation Systems (2004 - 2010)Responsible for overseeing the effective processes, procedures, systems and technical expertise to assure Quality Control in the production, retention, retrieval and publ ...
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