Phone (385) 259-2509
SUMMARY:
25+ years of Quality Systems experience in Semiconductor, Medical Device, Calibration and Aerospace Industries.
PROFESSIONAL EXPERIENCE
EXELIS ITT Senior Quality Engineer 2011-2012 Responsible for Ceramic and Underwater Acoustic ISO 9001/2000 and AS 9100 Quality Management Systems/programs. Completed Six Sigma Green Belt training with Michigan State University. Worked directly with operating entities to provide process analyses using Statgraphics or QE Tools to enforce requirements and meet guidelines. Lead Customer and Internal audit preparation, resolution of audit and inspection findings throughout all stages of the audits. Responsible for MRB/MRR team dispositioning and resolution of all non-conformances. Approved all Manufacturing Instructions/changes for Ceramic Production and Acoustic Sub-assemblies. Ensured the ISO 9000/AS 9100 policies/procedures are maintained and modified regularly.
GE HEALTHCARE Quality Assurance/Document Control Manager 2009-2011 Managed ISO 13485 and 21 CFR 820 compliant Document Control Department. Responsible for QMS, CAPA and QARA Internal Auditing. Implemented new ECN process/procedures for drawings/parts. Generated Quality Plans to ensure compliance to internal specifications and procedures. Performed Six Sigma/Kaizen process which improved DCN process cycle time by 30 percent. Supported Engineering in new product reviews from a Quality Perspective. Acted as the compliant resource for Document Control and external departments to ensure compliance to regulations/procedures. Responsible for assessing daily metrics for ECN/DCN processing and audit deficiencies for inclusion in Executive Quality Metric Reviews. 1 year Sabbatical taken. FLUKE CORP. – HART SCIENTIFIC Division Quality Manager 2005 to 2009 Managed ISO-017025:2005 Quality System for the Calibration Program/Activities and ISO-9001:2000 Compliance for the Factory. Managed entire Documentation Control activities for Company. Developed Quality Manuals and all supporting procedures/processes for both Cal Lab and Factory. Implemented Division long-term quality strategies, goals and objectives including a five year quality plan/road map. Insured compliance to Customer, NVLAP, Nuclear and GMP/FDA Audits by performing monthly Internal Audits and providing quick resolution to deficiencies. Implemented Supplier Quality and Internal inspection programs for the company. Provided Annual Quality, Six Sigma, TQC and SPC training for Company. Involved in Kaizen activities for implementing DBS Lean Manufacturing principles. NORTHROP GRUMMAN QA Program Manager 2002 to 2005 Managed AS9100 Quality System of contractor for Stage 2 and 3 of Minuteman Peacekeeper Missile. Performed surveillances on all critical processes at Subcontractors. Developed procedures/processes to Final inspect motors prior to Government inspection and shipment to Air Force. Developed software/processes for invoicing complicated documents (DD250) for motor shipments. Dispositioned all non-conformities and approved all C/A’s from the subcontractor. Involved in Source Inspection and...
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