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 ...
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J Givin Location: Lancaster, PA 17602 ... 1:2000 audits- registration, Preassessment, and surveillance. IRCA certification number 186177 Lead Auditor. December 2001 to present- John Givin Associates, Consultant in ISO 9001:2000 and supplier surveillance including Verify, Inc and Moody International. Write quality manuals, procedures, and work instructions. Designed quality management systems to ISO 9001:2000 international standard. January, 1999 to October, 1999 contract source inspection for Lockheed Martin and Northrup Grumman. April 1983 to October, 1997- Quality Services Corporation- Consultant to contract agencies in procurement quality. Duties included source inspection and surveillance of materials ( steel, stainless stee ...
95 hits
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J Huang Location: Newtown, PA 18940 ... ies, successful in bringing value, new technologies, quality, validation and compliance to new product development. Extensive experience in quality management and global regulatory compliance, integrated CAPA and Quality Management system, Document Management System, clinical research, commercializatio n of new technologies, infrastructure qualification and compliance, manufacturing automation systems and process improvement. Success has been acknowledged through out the excellent services to major pharmaceutical companies such as Almac Clinical Technologies, Eli Lilly, Johnson & Johnson, Abbott Lab, Novartis, Purdue Pharma, Dupont Pharm, MDS Pharma Services etc. Well known for leadershi ...
93 hits
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M Martini Location: Monaca, PA 15061 ... unty Monaca, PA Major in Liberal Arts, January 1991 - May 1993 EXPERIENCE NOVA Chemicals Monaca, PA DYLARK® Global Quality Manager, February 2008 – Present ♦ NOVA Chemicals reinstated the Quality role for DYLARK® Business, so I was re-hired. ♦Process Owner of the DYLARK® Automotive Business Plan. ♦ Same responsibilities as listed below in the DYLARK® Global Quality System Coordinator/DYLA RK® Quality Steering Committee Leader position, except now globally responsible for product quality and all external tollers in North America, Europe and Asia. ♦ Customer Complain ...
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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 ...
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E Mcdaniel Location: Lepper, PA 16233 ... ng skills can be fully utilized to achieve the goals and objectives of a progressive company. Professional Experience: Marquee, A Division of Commodore Corporation. Shippenville, Pa. (Formerly Astro Homes) December 08, 2003 to December 05, 2008 Quality Assurance Manager * Directly responsible for product under General Manager * Accountable for Certification of Manufacturing Plant * Assured compliance of product with codes & product specs. * Ensured that the quality assurance program was adequately administered * Provided technical support for production, dealers, and builders * Supervisor of ceiling build-up, ceiling set, & electrician * Assured reduction ...
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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 ...
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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 ...
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W Thomas Location: East Petersburg, PA 17520 ... of your product. Career Profile ACCOMPLISHED QUALITY ASSURANCE MANAGER offering a solid educational background, extensive experience and a strong record of progressive and diversified know-how in both quality assurance and manufacturing. Significant qualifications include: · Ability to effectively deliver basic and advanced quality related training material (SPC, ISO, 5S, 6-Sigma, etc.). · Demonstrated ability to lead efforts to attain ISO certification at company & site level. · Capable of providing ISO lead audit support to attain certification or to maintain and improve quality processes. · Possess strong presentation skills in t ...
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M Solt Location: Northampton, PA 18067 ... ity Assurance field using my experience and knowledge that I have gained. Education: Delaware Valley College of Science and Agriculture, Doylestown, Pa Bachelor of Science in Business Administration, 1997 Northampton Sr High School, Northampton, PA College Prep, 1993 Working Experience Sharp Corporation, Allentown Pa March 2005 - Present Quality Assurance Manager ® Supervise 1 QA Supervisor, 18 QA inspectors, 1 Label Technician and 4 Batch Record Reviewers ® Responsible for all QC activities, which include incoming inspection, in-process inspection and batch record review ® Assist with customer audits and implementing any necessary corrective actions ® Revise any operatin ...
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