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Degrees
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My Expert Service
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Implementation and maintenance of ISO9000 and quality management systems including:
Gap analysis, Training, Documentation, Internal auditing,
How to pass customer, regulatory and registrar audits,
Corrective action, Preventive action, Inspection and testing
Calibration, Control of Records,
Design, Product realization,
Contract review, Purchasing and supplier control, Customer satisfaction, Continual improvement, Management reviews,
Preassessments, Registration audits and Surveillence audits.
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Experience & Qualifications
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Certified Quality Engineer, ASQ CQE
Certified Lead Assessor ISO9001, RAB
Japanese manufacturing theories, 5S, Poke Yoke, Kaizen
Deming and Juran management philosophy
FMEA, control plans, PPAP, Gage R&R, MSA
Shewhart control charting methods, SPC
GMP QSR certified, trained, STAT-A-MATRIX
Process Validation certified, trained, STAT-A-MATRIX
Risk Management for Medical Devices ISO14971 certified, trained, STAT-A-MATRIX
CAPA ISO9001, ISO13485 certified, trained, STAT-A-MATRIX
Six Sigma Green Belt/Black Belt trained, STAT-A-MATRIX
Lean Manufacturing certified, trained, STAT-A-MATRIX
Internal Auditor/Process Auditing ISO9000, ISO13485 certified, trained, STAT-A-MATRIX
Managing Process Data for Continuous Improvement certified, trained, STAT-A-MATRIX
Visual Factory Management certified, trained, Saddle Brook Institute
Participated in ISO9000 consortiums
Over 30 years experience in quality management and engineering
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Available Modes Of Communication
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email/chat
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Contact
Phil Krzyzaniak
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