Experienced Quality Engineering Professional
HIGHLIGHTS OF QUALIFICATIONS
Quality Management Systems Experience, including ISO:9001 and FDA 21 CFR 820.
Skilled with Quality Concepts and Tools Knowledge (SPC, PDCA, DMAIC, FMEA, RCA, Cpk, Pareto, Histogram, Cause-Effect Diagrams, Flow Charts).
Skilled in Continuous Improvement and Correction Systems - 8D, DMAIC, PDCA and Quality Circles
Experienced with Root Cause and Corrective Action Systems, including validation and verification of activities.
Understanding of Life Cycle Processes and Process Validation.
Performed Quality Management Systems Auditing (to FDA 21 CFR 820).
American Society for Quality Certified Quality Process Analyst, Certified Quality Technician, Certified Quality Inspector, and Certified Quality Improvement Associate.
WORK EXPERIENCE
Global Product Quality Engineer, Pride Mobility Products Corp., Exeter PA, Nov 2009-Jan 2012
Overall Responsibilities: To improve the quality system and the performance of Original Equipment Manufacturers (OEMs) and reduce First Time Quality (FTQ) errors.
Regularly performed Quality System audits and Process Validation at OEMs, in US and China.
Ensured the execution of company quality goals.
Served as Enterprise-wide Product Category Quality Champion.
Implemented and maintained on-site final inspection activities.
Informed OEM Management of FDA Regulatory compliance requirements.
Worked with Purchasing and Engineering for Supplier approval and Quality Improvements.
Maintained Enterprise-wide reporting system for field complaints, monitored trending and corrective actions.
Worked with Produc...
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