MAJOR ACCOMPLISHMENTS: * Instrumental in increasing approximately $3 Million in revenues in the first year by developing and implementing a novel UV curing process to terminate stimulating hydro-gel used in the manufacture of neuro stimulating and sensing electrodes. * Saved approximately $2 Million in the first year by eliminating scrap, returned devices, customer complaints, legal suits and consulting fees by changing and improving the chemical formulation of a high volume sales medical device. * In three medical device class I, II and III manufacturers satisfied FDA's 483 letters with prior multiple findings and passed follow-up FDA's inspections with zero observations. Prepared, submitted and obtained FDA's clearance for three 510 (k). * Cross-trained QC/QA and Mfg. personnel improving their technical skills and eliminating errors thus ultimately increasing the quality of the products as well as company cost savings. * Trained approximately 400 employees (English/Spanish) in Total Quality Management, Statistical Process Control, Zero Defects (Philip Crosby) and ISO 9000 Quality concepts and philosophy. * Obtained for my employers the ISO 9001/2, EN46001:1996, Advanced Quality System AS 9100 certificates. Maintained ISO 9001/13485 Certifications and FDA Registrations with zero findings.

Highlights:

• Documentation
• Manufacturing
• Quality
• Quality Assurance
• Quality Control
• Complaints
• Test
• Audit
• Fraud
• Health Insurance