Dennis Vaughn

Dennis Vaughn Email and Phone Number

Contract Process Validation/Quality Assurance Engineer
Dennis Vaughn's Location
Fort Lauderdale, Florida, United States, United States
Dennis Vaughn's Contact Details

Dennis Vaughn work email

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About Dennis Vaughn

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.

Dennis Vaughn's Current Company Details

Contract Process Validation/Quality Assurance Engineer
Dennis Vaughn Work Experience Details
  • Heartware
    Contract Validation Engineer
    Heartware Jan 2012 - Apr 2017
    Miami Lakes, Fl
    Performed 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.
  • Boston Scientific
    Contract Supplier Quality Engineer
    Boston Scientific Oct 2009 - Dec 2011
    Doral, Fl
    Supplier QE for guide wire outsourcing to 4 suppliers
  • Gatorteknica
    Contract Process Validation/Qa Engineer
    Gatorteknica May 2008 - Oct 2009
    Contract process validation/quality assurance at 3-D Machining, Inc., in Riviera Beach, FL
  • Implant Logics
    Contract Quality Engineer
    Implant Logics Feb 2008 - May 2008
    Cedarhurst, Ny
    3 month contract to establish Quality System documentation for dental implant surgical assist process/tooling
  • Angiotech
    Contract Validation Engineer
    Angiotech Dec 2006 - Feb 2007
    Reading, Pa
    Suture packaging IQ, OQ, PQ, TMV protocols
  • 3D Medical Manufacturing, Inc.
    Qa Manager
    3D Medical Manufacturing, Inc. 2003 - 2006
    Riviera Beach, Fl
    QA Manager for a 98% medical device component CNC machining and finishing facility. Responsible for Receiving, QE, QC, Cleaning & Passivation, Shipping.
  • Micro Med Engineering
    Qa Manager
    Micro Med Engineering Sep 1997 - Jun 2003
    Miami Lakes, Fl
    Started as CNC Mfg Supervisor and moved into QA Manager role. Site was a 95% medical device component CNC machining and finishing facility
  • Cordis / Telectronics Pacing System
    Manufacturing Manager
    Cordis / Telectronics Pacing System May 1992 - 1997
    Heart Pacemaker Manufacturing Manager
  • Cordis Corporation
    Director Of Manufacturing
    Cordis Corporation 1986 - 1992
    Miami Lakes, Fl
    Director of Implantables Manufacturing

Dennis Vaughn Skills

Iso 13485 Process Validation Quality Systems Medical Devices Quality Assurance Iso Manufacturing Machining Iso 14971 Capa Validations Gage R&r Quality Engineering Quality Auditing Process Capability

Dennis Vaughn Education Details

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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