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Jose Ignacio Mora

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Jose Ignacio Mora

Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.

During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.

During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches

Live Webinar

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By: Jose Ignacio Mora

Nov. 8, 2024

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

Document control under 21 CFR Part 820 is often slowed by legacy habits. This 75-minute webinar introduces Lean Documents and Lean Configuration, which apply lean principles to how controlled docu…

Industry: Medical Devices   Duration: 75 Minutes   Time: 12:00 PM PDT | 03:00 PM EDT

Recorded Session

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By: Jose Ignacio Mora

Recorded Session

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

The Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR) are core building blocks for medical device design, manufacturing and cGMP compliance. Too often they beco…

Industry: Medical Devices   Duration: 60 Minutes  

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By: Jose Ignacio Mora

Recorded Session

Medical Device Software Per IEC 62304

For companies submitting software-enabled medical devices or Software as a Medical Device (SaMD) to the FDA, inadequate software documentation is one of the biggest risks: a 510(k) can be rejected…

Industry: Medical Devices   Duration: 60 Minutes  

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By: Jose Ignacio Mora

Recorded Session

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls turn user requirements, the voice of the customer, into technical design inputs, which then form the design specification, or design output. Because design controls require tracing…

Industry: Medical Devices   Duration: 90 Minutes