Timothy Hudson

Experience

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  Siemens Healthcare

  Jan 1986 - Jan 1994

  • Manufacturing Integration and Test Administrator

    Jan 1992 - Jan 1994

  • Senior Product Engineer

    Jan 1986 - Jan 1992
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  Lockheed Martin

  Jan 1994 - Jan 1997

  Quality Specialist
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  GE Healthcare

  Jan 1997 - Jan 2005

  • Wrote company quality manuals with emphasis on simplicity and streamlined quality system by eliminating over 50 process procedures while maintaining FDA regulatory compliance.• Achieved ISO9001 quality system certification on first-attempt with no direct reports, enabling business access to European market via application of CE mark under EU Medical Device Directives.• Achieved Six Sigma Green Belt Certification and met project goal of reducing cycle time in closing quality system corrective actions from 196 to 68 days, Sigma improvement from 0.0 to 0.98.• Completed Six Sigma project meeting cycle time reduction goal of dispositioning nonconforming material from 43 days to under 1 day. Show less

  • Program Quality Engineer

    Jan 2002 - Jan 2005

  • Quality Assurance Specialist

    Jan 1997 - Jan 2002
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  Baxter Healthcare

  Jan 2005 - Jan 2008

  Principal Quality Engineer

  Analyzed and compiled data concerning global technical services (GTS) process execution using statistical methods.• Drove process improvement by leading local service team to investigate trends.• Provided leadership through planning, directing, and coordinating activities of business metrology function.• Realized quality improvements via developing and executing internal quality audit program for service organization and conducting supplier quality evaluations for Baxter GTS suppliers.• Steered backroom activities during 2 regulatory compliance investigations of service organization by FDA and outside consultants, acting as subject matter expert in areas of calibration, data trending, and internal audit. Show less

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  Plexus

  Jan 2008 - Jan 2020

  Quality Engineer II

  Provided primary leadership in development of quality assurance mechanisms for assigned customers. Developed quality assurance plans, assembly / standard operating procedures (SOP) / work instructions, quality metrics, and failure analysis (FMEA).• Initiated immediate and on-going support in resolution of issues impacting product quality, especially non-conforming product (NCM), customer quality audits, corrective / preventive actions (CAPA), and interpretation of various data trends.• Spearheaded early efforts for HLA migration, with new customer (Qiagen) program leading to Plexus’ "Supplier of the Year" designation for 2 consecutive years.• Guided manufacturing facilities globally in production yield improvements of Siemens state-of-the-art ultrasound systems from 20% to over 85% first-pass yield (FPY).• Drove manufacturing gains of Medtronic Cardiac Ablation products, boosting production from 20% to over 80% FPY.• Executed program implementing full-service receiving inspection capability for Plexus Aftermarket Services, adding $300K in service depot revenue and allowing Plexus service depot to act independently from customer (Baxter) support. Show less

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  Jabil Healthcare

  Aug 2020 - Sept 2022

  Quality Engineer III

  I have retired (yay), but am open to short-term contract / part time opportunities if appropriate.