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Speaker Profile
JOSE IGNACIO MORA

José 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. 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.


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$199.00
ISO 13485 2015 utilizing Principles of Lean Documents and Lean Configuration

 Jose Ignacio Mora
 March 21 2025
 01 : 00 PM EST    
 90 Minutes
ISO 13485 2015 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 ev..

$199.00
Risk Management for Medical Devices per ISO 14971

 Jose Ignacio Mora
 April 17 2025
 01 : 00 PM EST    
 60 Minutes
Risk Management for Medical Devices per ISO 14971

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.During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or to the environment during all s..

$199.00
Chipping away at constraints – Practical tips to improve your manufacturing operations

 Jose Ignacio Mora
 May 12 2025
 01 : 00 PM EST    
 60 Minutes
Chipping away at constraints – Practical tips to improve your manufacturing operations

Many times, your manufacturing operation seems very busy, yet the throughput of the entire line is poor. We often confuse busy and efficient with productive. This webinar is based on real-life examples and how simple techniques were used to improve overall productivity without the need to spend weeks performing complex modeling and analysis.Areas CoveredIdentifying a constraint in a process by its symptoms...

$199.00
Process Validation Requirements And Compliance Strategies

 Jose Ignacio Mora
 June 09 2025
 01 : 00 PM EST    
 60 Minutes
Process Validation Requirements And Compliance Strategies

When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.Areas CoveredGlobal Harmonization Task Force requirements (includes FDA and ISO)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Design QualificationFacilities and utilitiesStrategies for achieving a robust and reliable process.Typical..

$199.00
Risk-based Design Control - The New Paradigm for Medical Device Design

 Jose Ignacio Mora
 July 09 2025
 01 : 00 PM EST    
 60 Minutes
Risk-based Design Control - The New Paradigm for Medical Device Design

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 awkwardly, this webinar will give you a different perspective and a very different approach that you can use.If your design and manufacturing resources spend too much time on documentation and no..

$199.00
Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

 Jose Ignacio Mora
 August 12 2025
 01 : 00 PM EST    
 90 Minutes
Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

Which do YOU want to be?  Only you can answer that.  This webinar can show you how to be the latter:Old school remediation:    Hire 50 consultants tribal knowledge    Put them to work on a PUSH system    Build mountains of work-in-progress    Bury your information in folders    Spend endless hours on rew..

$199.00
Supplier and Contract Manufacturer Management

 Jose Ignacio Mora
 September 08 2025
 01 : 00 PM EST    
 90 Minutes
Supplier and Contract Manufacturer Management

This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for an exit. The course will show attendees how to use risk assessment for ranking suppliers and reducing the number of audits ..

$199.00
Creating a Quality Management System (QMS) Utilizing Principles of Lean Documents and Lean Configuration

 Jose Ignacio Mora
 October 14 2025
 01 : 00 PM EST    
 90 Minutes
Creating a Quality Management System (QMS) Utilizing Principles of Lean Documents and Lean Configuration

Overall, creating a QMS in the life sciences requires a commitment to quality, compliance, and continuous improvement. It involves a collaborative effort across all levels of the organization, from management to frontline staff, to ensure that quality is built into every aspect of the product, service, or process.The use of design controls is an innovative yet proven method for product and process developme..

$199.00
Compliance Audit Using Principles of Lean Documents and Lean Configuration

 Jose Ignacio Mora
 November 11 2025
 01 : 00 PM EST    
 90 Minutes
Compliance Audit Using Principles of Lean Documents and Lean Configuration

This webinar describesEnhance your knowledge: Compliance auditing is a critical aspect of any organization's governance framework. By attending this webinar, you will gain a comprehensive understanding of compliance auditing principles, methodologies, and best practices. This knowledge will enable you to strengthen your compliance program and contribute to your organization's overall risk management strateg..

$199.00
Effective Technical Writing: Improving Your Skills for Clear and Concise Communication

 Jose Ignacio Mora
 December 18 2025
 01 : 00 PM EST    
 90 Minutes
Effective Technical Writing: Improving Your Skills for Clear and Concise Communication

In the realm of medical device manufacturing, the clarity and precision of technical documentation are non-negotiable. This webinar is your opportunity to:Elevate Your Skills: Enhance your technical writing abilities to meet the industry's rigorous standards.Stay Compliant: Stay up to date with regulatory requirements and guidelines.Improve Communication: Learn strategies to convey complex information clear..

$199.00
Continuous Improvement Using 7 Basic Quality Tools

 Jose Ignacio Mora
 January 13 2026
 01 : 00 PM EST    
 60 Minutes
Continuous Improvement Using 7 Basic Quality Tools

Without continuous improvement, you are at risk of going out of business and quickly. Yet, with many, and mostly expensive continuous improvement methodologies, it is expensive and hard to implement and drive continuous improvement in any organization.Hence, going back to the basics is the solution - and the best solution, if you want to achieve your corporate objectives and beat the competition.Areas Cover..

$199.00
Reclassification of Software Automated Medical Devices

 Jose Ignacio Mora
 February 19 2026
 01 : 00 PM EST    
 90 Minutes
Reclassification of Software Automated Medical Devices

Without continuous improvement, you are at risk of going out of business and quickly. Yet, with many, and mostly expensive continuous improvement methodologies, it is expensive and hard to implement and drive continuous improvement in any organization.Hence, going back to the basics is the solution - and the best solution, if you want to achieve your corporate objectives and beat the competition.Areas Cover..

Showing -29 to -15 of 19 (2 Pages)
$200.00
Supervisor Accountability and Responsibility for Employee Safety and Health

 Jose Ignacio Mora
 Recorded Webinar
 90 Minutes
Supervisor Accountability and Responsibility for Employee Safety and Health

Running any business enterprise is tough enough on a good day. There are about 32.5 million small businesses in the US, which account for 99.9 percent of all US businesses (SBA, 2021). The Small Business Administration (SBA) defines a small business as a firm that has fewer than 500 employees. This metric will be the focus of our discussion. And that’s a big number How a business or organization approaches ..

$200.00
Export Due Diligence: What Every U.S. Exporter Must Know?

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
Export Due Diligence: What Every U.S. Exporter Must Know?

Provisions in the Export Administration Regulations (EAR) require that exporters know their exports, destinations, end-users, and end uses. Exporters must submit an individual validated license application if the exporter "knows" that an export that is otherwise exempt from the validated licensing requirements is for end-uses involving nuclear, chemical, and biological weapons or related missile delivery sy..

$200.00
Management Accounting and the Cost of Quality

 Jose Ignacio Mora
 Recorded Webinar
 60 Minutes
Management Accounting and the Cost of Quality

Managing quality is an imperative for any organization to remain competitive. Measurements of quality are essential, however supplementing that information with financial information further adds to success in managing quality.Ultimately the language of money is what executives and managers rely on to make better decisions.Unfortunately, most financial reporting neglects to report quality information such a..

Showing -29 to -15 of 19 (2 Pages)