José Ignacio Mora
Inhaber, Principal Consultant & Owner, Atzari Consulting, L.L.C. (New York)
Pompton Lakes, Vereinigte Staaten
Werdegang
Berufserfahrung von José Ignacio Mora
Bis heute 17 Jahre und 11 Monate, seit Aug. 2006
Principal Consultant & Owner
Atzari Consulting, L.L.C. (New York)
Hands-on consultant as well as co-owner of the company.
3 Jahre und 2 Monate, Apr. 2005 - Mai 2008
Senior Consultant
Streale Enterprises
Experienced lifesciences consultant in Quality Systems trained to confiture and test Pilgrim SmartCAPA, Pilgrim SmartAudit, etc.
1 Jahr und 7 Monate, Juni 2003 - Dez. 2004
Director of Manufacturing Engineering
Boston Scientific
Director over Manufacturing Engineering, Strategic Initiatives, Packaging Engineering, and Materials Engineering. Approximately 30 people reported into my organization.
1 Jahr und 8 Monate, Nov. 2001 - Juni 2003
Quality Systems Manager
Stryker Orthopaedics
• Re-designed and wrote Process Validation procedure and standards, bringing plant into compliance with GHTF standard. • Resolved major product and process failures pinpointing and permanently eliminating root causes. • Recognized as resident expert in use of Kepner-Tregoe® and Taguchi for process development and failure investigation. • Complete reorganization of Calibration Lab using lean and 5S visual workplace methods.
1 Jahr und 3 Monate, Aug. 2000 - Okt. 2001
Principal Consultant & Owner
Atzari Consulting, L.L.C. (Georgia)
• Designed a new Device Master Record system for startup client’s first product during a time when they lacked an electronic system. Corrected over 1,000 non-conformances in a six-month period, prior to FDA qualification audit, resulting in successful audit by FDA.
2 Jahre und 6 Monate, Jan. 1998 - Juni 2000
Director of Manufacturing
UroSurge, Inc.
• Designed, built, validated, and managed world-class manufacturing operation for urology instruments and implants. • Designed and instituted complete JIT/Lean kanban system from receiving to shipping, including outsourced sterilization. • Configured MRP 9000 database for BOMs, routers, purchasing, and manufacturing.
2 Jahre und 4 Monate, Juli 1995 - Okt. 1997
Engineering Manager
Mentor Corporation
• Grew department from staff of 5 engineers, to fully functional department of 30 engineers and 3 section managers. • Introduced successful use of Kepner-Tregoe® and Taguchi techniques, training over 30 engineers, leading to the successful process validation of the RTV shell coating line that had zero-defects for shell thickness, for the first time in 20 years. • Introduced self-managed cross-functional improvement team concept, improving yields from 50% to above 85%.
3 Jahre und 6 Monate, 1992 - Juni 1995
Manufacturing Engineering Manager
Cordis Corporation (Johnson & Johnson)
• Led manufacturing engineering team to the complete re-design of the Fr. 8/.084 guiding catheter product and process, a product which became market leader over a period of two years. • Led company-wide redesign of entire tooling system, resulting in elimination of uncontrolled satellite tooling
Ausbildung von José Ignacio Mora
4 Jahre und 9 Monate, Sep. 1975 - Mai 1980
Mechanical Technology
Purdue University, West Lafayette, IN
Hydraulics and hydrostatics; manufacturing technology
Sprachen
Englisch
Fließend
Spanisch
Muttersprache