José Ignacio Mora

Hands-on consultant as well as co-owner of the company.

Experienced lifesciences consultant in Quality Systems trained to confiture and test Pilgrim SmartCAPA, Pilgrim SmartAudit, etc.

Director over Manufacturing Engineering, Strategic Initiatives, Packaging Engineering, and Materials Engineering. Approximately 30 people reported into my organization.

• 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.

• 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.

• 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.

• 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%.

• 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

Hydraulics and hydrostatics; manufacturing technology