Speaker Profile

Jose
Jose Mora
Principal Consultant, Atzari Consulting, LLC

Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device 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.

José 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 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, orthopedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José 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 Ss (Visual Workplace), process validation to GHSS standards, and similar approaches.

Upcoming Webinars Recorded Webinars
Jose Mora

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 maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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 maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

Risk Management Utilizing Lean Documents and Lean Configuration

If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

Effective Design of Experiments (DOE) Strategies

This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

Speaker: Jose Mora | View Anytime | Price: $190.00 | View Details
Jose Mora

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

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jose Mora

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 method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

Controlled Document System for a Life Sciences Manufacturing Plant - 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.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jose Mora

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 method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

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 method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Jose Mora

Managing The Audit Function In A Global Company

This presentation focuses on the role, skills, organizational opportunities, and the benefits of an independent audit group to advise senior management on the true causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Jose Mora

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 maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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 maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) Do you find yourself constantly struggling to create, manage, and maintain all of the information found in DHFs, DMRs, and DHRs - which is often redundant, repetitive, and chained together in a cumbersome way?

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

Risk Management Utilizing Lean Documents and Lean Configuration

If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

Effective Design of Experiments (DOE) Strategies

This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

Speaker: Jose Mora | View Anytime | Price: $390.00 | View Details
Jose Mora

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

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Jose Mora

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 method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Jose Mora

Controlled Document System for a Life Sciences Manufacturing Plant - 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.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Jose Mora

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 method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Jose Mora

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 method must be reliable both in detecting defects and in not rejecting acceptable samples

Speaker: Jose Mora | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Jose Mora

Managing The Audit Function In A Global Company

This presentation focuses on the role, skills, organizational opportunities, and the benefits of an independent audit group to advise senior management on the true causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.

Speaker: Jose Mora | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details