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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.
Jose´ worked for 10 years at Cordis Corporation 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, 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 the fourth place.
By introducing world-class techniques, the Guiding Catheter design and manufacturing were 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.
17 results Found
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
On-Demand Webinar
(DHF), (DMR) (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 ...
- Basic & Intermediate
- 90 Mins
Recorded Webinar
Test Method Validation to Verify your Device Performance
This webinar will help you have an understanding of Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements, and how to perform successful TMV to ensure your inspection of verification is effectiv ...
- Basic & Intermediate
- 60 Mins
Recorded Webinar
Corrective and Preventive Action (CAPA)
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 ...
- Basic & Intermediate
- 90 Mins
On-Demand Webinar
FDA Regulation of Artificial Intelligence & Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and g ...
- Basic & Intermediate & Advanced
- 60 Mins
Recorded Webinar
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 ...
- Basic & Intermediate & Advanced
- 60 Mins
On-Demand Webinar
Process Validation Requirements & Compliance Strategies
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving ...
- Intermediate
- 60 Mins
Free 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