Highly experienced in continuous improvement, engineering, quality assurance, quality management, and regulatory compliance with global reach.ASQ Certified Manager of Quality/Organizational Excellence since 2000Degree in Industrial Engineering.Expert in Quality Management System implementation, particularly ISO9001 and ISO13485.Highly practiced in project management, continuous improvement, and quality management systems implementation, supplier quality.Experience in electronics manufacturing, medical device, pharmaceuticals, paper converting, plastic molding, contract packaging, printing, plastic extrusion and fabrication, pressure relief device manufacturing, pharmaceutical label printing.In depth knowledge of FDA cGMP's for drug, device and cosmetics; REACH and RoHS compliance; CE marking.Specialties: Lean, Quality Systems Implementation and Improvement, Quality Management, Leadership, Regulatory Compliance, Project Management, ISO9001, ISO 13485, MDD, Internal and Supplier Quality Auditing, Product Development Process, Cosmetics, Food, Pharmaceutical, consumer products, Pressure relief devices, FMEA/Control Plan, Root Cause Analysis, IPC-A-610, IPC/WHMA-A-620
Listed skills include Quality System, Quality Management, Manufacturing, Lean Manufacturing, and 53 others.