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RETIRED. Extensive direct employee medical device and component manufacturing experience primarily in manufacturing and quality assurance management. Last 10 years have been in contract process validation/Quality Assurance/Supplier Quality engineering prior to mostly working for my own corporation (GatorTeknica). Goal is to stay productive, stay healthy and to continue supporting medical device or component process validation and QA opportunities.Specialties: Quality Systems documentation and implementation in compliance with ISO 9000, ISO 13485, CFR along with Process Validation skills (pFMEA, MVP, IQ, OQ, PQ, TMV), including recent DI water systems validation and medical device cleaning validation.
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Contract Validation EngineerHeartware Jan 2012 - Apr 2017Miami Lakes, FlPerformed Process & Product cleaning validation for 2nd generation ventricular assist device. Performed DI water system validation. Tasks included Class III medical device TMV, IQ, OQ, PQ assignments. All validation work included protocol generation/approval, material acquisition with SME approvals, establishing/coordinating outside Microbiology lab testing, protocol execution, and report generation/approval. All validation task stages met HeartWare document control/change order requirements.
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Contract Supplier Quality EngineerBoston Scientific Oct 2009 - Dec 2011Doral, FlSupplier QE for guide wire outsourcing to 4 suppliers -
Contract Process Validation/Qa EngineerGatorteknica May 2008 - Oct 2009Contract process validation/quality assurance at 3-D Machining, Inc., in Riviera Beach, FL
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Contract Quality EngineerImplant Logics Feb 2008 - May 2008Cedarhurst, Ny3 month contract to establish Quality System documentation for dental implant surgical assist process/tooling
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Contract Validation EngineerAngiotech Dec 2006 - Feb 2007Reading, PaSuture packaging IQ, OQ, PQ, TMV protocols
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Qa Manager3D Medical Manufacturing, Inc. 2003 - 2006Riviera Beach, FlQA Manager for a 98% medical device component CNC machining and finishing facility. Responsible for Receiving, QE, QC, Cleaning & Passivation, Shipping.
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Qa ManagerMicro Med Engineering Sep 1997 - Jun 2003Miami Lakes, FlStarted as CNC Mfg Supervisor and moved into QA Manager role. Site was a 95% medical device component CNC machining and finishing facility
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Manufacturing ManagerCordis / Telectronics Pacing System May 1992 - 1997Heart Pacemaker Manufacturing Manager
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Director Of ManufacturingCordis Corporation 1986 - 1992Miami Lakes, FlDirector of Implantables Manufacturing
Dennis Vaughn Skills
Dennis Vaughn Education Details
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Industrial Engineering
Frequently Asked Questions about Dennis Vaughn
What is Dennis Vaughn's role at the current company?
Dennis Vaughn's current role is Contract Process Validation/Quality Assurance Engineer.
What is Dennis Vaughn's email address?
Dennis Vaughn's email address is dv****@****ail.com
What is Dennis Vaughn's direct phone number?
Dennis Vaughn's direct phone number is +195424*****
What schools did Dennis Vaughn attend?
Dennis Vaughn attended University Of Florida.
What skills is Dennis Vaughn known for?
Dennis Vaughn has skills like Iso 13485, Process Validation, Quality Systems, Medical Devices, Quality Assurance, Iso, Manufacturing, Machining, Iso 14971, Capa, Validations, Gage R&r.
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Dennis Vaughn
Denver Metropolitan Area3gmail.com, mojorank.com, quantumelite250.com3 +180173XXXXX
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3yahoo.com, carehospice.com, bobsredmill.com
1 (503) 6XXXXXXX
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Dennis Vaughn
Grayslake, Il1baxter.com3 +184794XXXXX
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