Generic placeholder image

Jose Mora

Jose Mora is Keynote Speaker at Compliance key Inc.He 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. Jose worked for 10 years at a Johnson & Johnson company Corporation, now a Johnson & Johnson company, where he led the successful tooling, process development and qualification of Cordi's 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 a Johnson & Johnson company, 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 a a Johnson & Johnson company 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.

 Webinar Id: LSHCSJM003
 View Anytime
 Duration 90 mins

Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Utilizing suppliers as an extension of an organization's design and manufacturing capabilities presents unique challenges.

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCJMAA002
 View Anytime
 Duration 90 mins

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 lean vs. non-lean documents.

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCJM004
 View Anytime
 Duration 90 mins

ISO 13485 2016 utilizing Principles of Lean Documents and Lean Configuration

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2015 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing proce........

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCJM001
 View Anytime
 Duration 60 mins

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

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment........

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCJM00113
 View Anytime
 Duration 60 mins

Creation of DHFs, DMRs, and DHRs utilizing the 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" systems, many traditional document practices are artifacts of a flawed approach. Lean documents presents a fresh departure from these practices, while building upon proven principl........

$ 237  Recorded  (6 months unlimited access)

View Details

 Webinar Id: LSHCCJM003
 View Anytime
 Duration 60 mins

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

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipmen........

$ 237  Recorded  (6 months unlimited access)

View Details

    
Copyright © 2017 Compliance Key . All Rights Reserved. Back to Top