Engineer Quality
Resume:
DAVID G. THOMPSON, ASQ-CCT, CQE, CQA
ROCHESTER, NEW YORK
E-MAIL: *********@****.***.***
PROFESSIONAL PROFILE
Accomplished Quality Assurance professional with 27 years of experience in Quality Systems, specifically CAPA, Quality Engineering, Auditing, Calibration Systems and Equipment Validations in the medical device and related industries. AREAS OF EXPERTISE
> ISO 13485, MDSAP and EU MDR Auditing > Calibration and PM System Management
> Supplier Quality > Equipment and Process Validations (IQ/OQ/PQ)
> Quality Systems > Corrective and Preventive Action (CAPA)
> Training Management > ISO 13485, AS9100 and ISO 9001 Management
> Document and Record Control > cGMP: 21 CFR part 820, CMDR, EU MDR, TG(MD)R
> Change Management > Problem Solving
> Statistical Quality Analysis (Minitab, SAS) > Cleanroom certification (ISO 14644) PROFESSIONAL EXPERIENCE
Quality Assurance Manager (April 2018 – February 2020), Senior Quality Assurance Engineer (March 2020 – present). LSI Solutions, Victor, NY
Senior Quality Assurance Engineer Responsibilities:
Managing the internal audit program through supporting internal and supplier audit team training and competency, developing the internal and supplier auditing schedule, serving as a lead auditor, and supporting external audits as needed.
Quality Assurance Manager Responsibilities:
Leading internal and supplier audits
Leading and managing the Quality Assurance department.
Managing regulatory compliance of quality management system to standards and regulations through the gap assessment process and an effective review of updates to top level procedures.
Leading quality system and compliance improvement initiatives, specifically compliance, auditing and CAPA processes.
Managing the CAPA program through supporting CAPA related personnel competency, ensuring resource availability, developing CAPA and root cause analysis expertise throughout the organization, and continuously monitoring and evaluating the CAPA process.
Leading, facilitating, coordinating and/or supporting CAPA activities, including but not limited to problem statement development, root-cause investigation, corrective action development, implementation, and verification of effectiveness plan development.
Managing of electronic QMS software (Grand Avenue Software) modules for CAPA, Document Control, Training, and Nonconforming Material.
Managing document control process and Document Control Associates.
Managing Quality training process and Training Coordinator.
Support supplier quality, preventive maintenance and calibrations functions as needed. Senior Quality Engineer (January 2016 – March 2018); Quality Engineer (June 2014 – December 2015), LSI Solutions, Victor, NY
Responsibilities:
Leading internal and supplier audits.
Quality related supplier interface activities.
Coordination of non-conforming material reports and activities, particularly associated with incoming material.
Supervision of incoming and in-process inspection quality technicians, as well as Finished Goods Quality Technicians.
Coordination of PM and Calibration database through transition to scheduling using IQMS ERP system D. Thompson - Page 2
Review, revision, and approval of quality procedures, work instructions, inspection plans, protocols, reports, and design documents.
Assist Quality Systems Manager with Lean initiatives in inspection lab.
Train personnel to procedure revisions as needed.
Consultation on statistical analyses and sample size rationales when needed. Quality Engineer (February 2014 – May 2014), API Technologies, Fairport, NY Responsibilities:
Assisting the Quality Manager with the internal audit program and serving as escort for AS9100 surveillance audit.
Coordination of all nonconformance and CAPA activities for prototype department.
Review and revision of quality procedures and work instructions when needed.
Facilitation of weekly CAPA open action items meetings. Engineer I, Metrology (February 2009 – May 2013); Quality Supervisor (June 2013 – December 2013), Bausch & Lomb
(B+L), Rochester, NY
Supervisor Responsibilities:
Execution of supervisory duties including personnel and budgetary responsibilities for the Calibration Services department / Rochester Plant Quality, consisting of 5 Calibration Technicians.
Coordination of all calibration related Non-Conformances and related Corrective and Preventive Actions and Root Cause Investigations using CATSWeb.
Facilitation of all calibration related Quality Change Requests, such as SOP and other documentation changes.
Remaining duties as described below in Group Leader responsibilities. Engineer, Group Leader Responsibilities:
Extensive use of and assistance in the management and maintenance of the calibration database, Blue Mountain Quality Resources, Inc.™ Calibration Manager® v 4.2 (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. Quality Engineer (June 2008 – September 2008); Calibration Technician (June 2002 – April 2005); Instrumentation and Calibration Associate (April 2005 – June 2008), Angiotech BioCoatings Corp. (fka STS Biopolymers, Inc.)– Henrietta, NY
Calibration Technician III (June 1998 – June 2002), Metrologist I (June 2002 - June 2004) and Equipment and Validation Specialist (June 2004 – April 2005), STS, Inc. (including STS duoTEK, Inc., STS Biopolymers, Inc., and STS Particles, Inc.), Rush & Henrietta, NY
Electrical Technician (May 1994 – September 1997) and Repair Department Group Leader (September 1997 – May 1998), Transmation, Inc., Rochester, NY
EDUCATION AND CERTIFICATION
Exemplar Global - EU MDR Auditor Training, October 2019 Exemplar Global –Internal Auditing to MDSAP, August 2019 Exemplar Global – ISO 13485 Certified Lead Auditor, February 2016 American Society for Quality Certified: Quality Auditor, June 2015; Quality Engineer, December 2009; Calibration Technician, December 2005
Masters of Science in Applied Statistics, Rochester Institute of Technology, 2012, GPA 4.00 Advanced Graduate Certificate in Statistical Quality, Rochester Institute of Technology, 2009, GPA: 4.00 BS in Electrical Engineering, Rochester Institute of Technology, 1991, GPA: 3.14
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