David G. Thompson

Experience

• 

  Transmation, Inc.

  May 1994 - May 1998

  Primary Responsibilities:• Manufacturing, inspection, calibration, troubleshooting, and repair of electrical measurement and test equipment• Coordination of the technical, financial, and customer service aspects of the repair department along with supervision and execution of repair department activities• Extensive interaction with all other departments within the company as well as with clients, requiring the development of communication and team building skills• Internal Auditing to ISO 9001 Show less

  • Repair Department Group Leader

    Sept 1997 - May 1998

  • Electrical Technician

    May 1994 - Sept 1997
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  STS duoTEK, Inc.

  Jun 1998 - Jun 2004

  Primary Responsibilities:• Management of the calibration systems for STS group of companies• Preparation and assistance to QA in maintenance of NIST traceable quality records documenting calibrations• Preparation and execution of equipment Installation Qualifications and Re-Qualification protocols• Implementation, integration, management, and maintenance of the calibration database, CalMan v 3.0• Coordination with numerous vendors of outsourced calibration and repair activities• Consultation with operational departments regarding the selection, purchase, use and specifications of measurement and test equipment• Preparation and revision of calibration related SOP’s• Participation in quality audits while insuring the calibration program satisfied ISO 17025 where applicable, ISO 13485 and cGMP regulations• Service as the chairperson on the Emergency Response Team (September 1998 – June 2002) and the Safety Policy Committee / ERT (June 2002 – April 2005) at STS Show less Primary Responsibilities:• Management of the calibration systems for STS group of companies• Preparation and assistance to QA in maintenance of NIST traceable quality records documenting calibrations• Preparation and execution of equipment Installation Qualifications and Re-Qualification protocols• Implementation, integration, management, and maintenance of the calibration database, CalMan v 3.0• Coordination with numerous vendors of outsourced calibration and repair activities• Consultation with operational departments regarding the selection, purchase, use and specifications of measurement and test equipment• Preparation and revision of calibration related SOP’s• Participation in quality audits while insuring the calibration program satisfied ISO 17025 where applicable, ISO 13485 and cGMP regulations• Service as the chairperson on the Emergency Response Team (September 1998 – June 2002) and the Safety Policy Committee / ERT (June 2002 – April 2005) at STS Show less

  • Metrologist I

    Jun 2002 - Jun 2004

  • Calibration Technician III

    Jun 1998 - Jun 2002
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  STS Biopolymers, Inc.

  Jun 2002 - Apr 2005

  Calibration Technician

  Primary Responsibilities:• Management and execution of the calibration systems and database for the entire company• Preparation of all NIST traceable documentation to support the calibrations• Consultation with operational departments regarding the selection, purchase, use and specifications of measurement and test equipment• Initiation of corrective action requests when needed• Insurance that the calibration program remained within ISO 17025 where applicable, ISO 13485, and cGMP requirements Show less

• 

  Ethox International

  Jun 2004 - Apr 2005

  Equipment and Validation Specialist

  Primary Responsibilities• Management and administration of the calibration program including the calibration database, CalMan, as described in Metrologist I and Calibration Technician III positions below• Training of and working with the calibration technician to complete calibration tasks• Administration of the integration of the calibration management software, CalMan, into the company’s overall equipment management program, including PM, Qualification, and Calibration• Performance of equipment validations from shakedown testing to preparation of IQ/OQ/PQ protocols and reports to execution of the protocols, reviewing data and reviewing documentation• Participation on Equipment Validation Team dealing with the preparation and implementation of the Validation Master Plan and the STS validation program and validation related SOP’s• Participation in quality audits while insuring the calibration program satisfied ISO 17025 where applicable, ISO 13485 and cGMP regulations Show less

• 

  Corza Wound Closure

  Apr 2005 - Sept 2008

  Primary Responsibilities:• Performance of corrective and preventive action (CAPA) analysis, investigation, review, and trending• Review and compilation of product experience data• Review and trending of quality system indicators (e.g. manufacturing and environmental data)• Review and approval of documents pertaining to manufacturing processes such as batch records and validations (e.g. perform critical review of statistical rationale, utilizing Minitab)• Internal and Supplier Audits• Creation and management of stability, packaging and sterilization studies Show less Quality Assurance Responsibilities:• Work instruction, SOP and production batch record reviews with insurance of compliance to current Good Manufacturing Practices CFR parts 210 and 820 (cGMP) and ISO 13485 requirements• Initiation and maintenance of Out-of-Tolerance Reports for equipment as part of CAPA SystemEquipment Management Responsibilities:• Management and execution of the calibration program for the company as described in the Calibration Technician position below• Implementation, integration, management, and maintenance of equipment management database, Calibration Manager® v. 4.0 by Blue Mountain Resources (CalMan) for Preventive Maintenance, Equipment Qualifications, and Calibration• Oversight and optimization of the preventive maintenance program• Preparation, execution, and review of equipment Installation Qualification and Certification protocols and reports, including Packaging Validations per ISO 11607 and Cleanroom certifications per ISO 14644 Show less

  • Quality Engineer

    Jun 2008 - Sept 2008

  • Instrument and Calibration Associate

    Apr 2005 - Jun 2008
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  Bausch + Lomb

  Feb 2009 - Dec 2013

  • Executed duties of Group Leader for the Calibration Services department / Rochester Plant Quality.• Extensive use of and assistance in the management and maintenance of the calibration database, Blue Mountain Quality Resources, Inc.™ Calibration Mananager® v 4.0 (CalMan)• Performance of calibration documentation audits and weekly calibration task scheduling for five technicians in the Calibration Services department• Coordination of outsourced calibration and repair of reference standard measurement and test equipment (M&TE), including maintenance of department’s approved supplier list and vendor files• Assistance to department management in implementing quality optimization measures for the department• Writing and revision of department SOP’s in Documentum• Investigation and root cause analyses, where applicable, for Out-of-Tolerance M&TE, using CATSWeb• Execution of calibrations when needed• Participation in quality audits while insuring the calibration program satisfies ISO 17025 where applicable, ISO 13485 and cGMP regulations• Consultation with operational departments regarding the specifications and capabilities of M&TE. Show less

  • Quality Supervisor, Calibration Services

    Jun 2013 - Dec 2013

  • Engineer I, Metrology

    Feb 2009 - May 2013
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  Spectrum Control

  Feb 2014 - May 2014

  Quality Assurance Engineer
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  LSI SOLUTIONS®

  Jun 2014 - Jul 2021

  Responsibility for the internal audit program, specifically:Aligning the program with the MDSAP audit approach and the EU MDR;Constructing the audit team and training the new auditors; andScheduling audits and determining the audit scopes, objectives and criteria. Manage the document control, training, external standards management personnel, perform internal audits, champion CAPA teams and perform supplier audits, Supervise Incoming and In-Process Inspection teams, perform internal audits, work in supplier quality, perform supplier audits, coordinate non-conforming material reports, participate on CAPA teams, consult on preventive maintenance and calibration systems,

  • Senior Quality Assurance Engineer

    Feb 2020 - Jul 2021

  • Quality Assurance Manager

    Mar 2018 - Feb 2020

  • Senior Quality Engineer

    Jan 2016 - Mar 2018

  • Quality Engineer

    Jun 2014 - Dec 2015
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  Corning Incorporated

  Jul 2021 - now

  Quality Supervisor