Mr.José Mora

Area Of Expertise : Quality
30 Years Of Experience
Training Industry : Life Sciences

Jose Ignacio 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, Jose´ 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.

 

 

26 results Found
Live Webinar

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

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.   Just as lean principles challenge traditional process concepts and "push ...

  • Intermediate
  • 90 Mins
  • Aug 07, 2024
Live Webinar

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.   For example, while a defect-free process is desirable, a test ...

  • Intermediate
  • 90 Mins
  • Aug 13, 2024
Live Webinar

Design Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design c ...

  • Basic & Intermediate
  • 90 Mins
  • Sep 10, 2024
Live Webinar

An Advanced Course on Lean Documents, Lean Configuration and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...

  • Basic & Intermediate
  • 90 Mins
  • Sep 19, 2024
Recorded Webinar

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect.   For example, while a defect-free process is desirable, a test ...

  • Intermediate
  • 90 Mins
Recorded Webinar

Risk-based Design Control - The New Paradigm for Medical Device Design

Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.  Design control is not only a requirement of t ...

  • Intermediate
  • 60 Mins
Recorded Webinar

An Advanced Course on Lean Documents, Lean Configuration and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

Design Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs.  These design inputs then form the basis of the design specification, which becomes the design output.  Since design ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Test method validation is an often-confusing requirement for medical devices.  A fundamental issue is the role reversal between the test method and the product or process it is designed to detect.  For example, while a defect-free process is desirable, a test ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

An Advanced Course on Lean Documents, Lean Configuration, and Document Control

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...

  • Basic & Intermediate
  • 90 Mins