Expert Profile
Jose Mora
Principal Consultant, Atzari Enterprises
Jose 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, now 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, orthopaedic 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 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.
Trainings by Expert
Process Validation Requirements & Compliance Strategies
Category:
Medical Devices
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FDA Validation
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Supply Chain and Manufacturing
,
Life Sciences
Effective DOE Strategies to Streamline your Processes for FDA Regulated Environment
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
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All FDA Regulated Industry
,
FDA Validation
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Quality and Safety
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Supply Chain and Manufacturing
,
Life sciences QA/QC
,
Life Sciences
,
QA/QC
Best Practices on Six Sigma and CAPA Convergence
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
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All FDA Regulated Industry
,
Quality Management
,
Quality and Safety
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QMS, ISO 13485, CAPA
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Laboratory
,
Best practices
,
Life sciences QA/QC
,
Best Practices & GXPs
,
Life Sciences
,
QA/QC
Parallel trade of medicinal products in the EU - Latest case law and Commission decisions
Category:
Drugs and Chemicals (Pharma)
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Medical Devices
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Supply Chain and Manufacturing
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Regulations & Guidances
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Life Sciences
,
Regulatory Affairs
Medical Device QSR (21 CFR Part 820), Design Control, Hazard Analysis Under ISO 14971 and ICH Q9: Pack of 3 Courses
Category:
Medical Devices
Lean Documents and Document Control
Category:
General Manufacturing
,
Quality Management
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Tools and techniques
,
Quality management tools
,
QA/QC
Applying Lean Documents to a Project - how to create a project file, follow design controls, yet maintain a lean set of project documents
Category:
Quality Management
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GXP Pharmaceutical
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Tools and techniques
,
Quality management tools
,
QA/QC
Using Kanban JIT Systems to Run a Startup Plant
Category:
Medical Devices
,
Energy & Utility
,
Quality Management
,
Life Sciences
An Advanced Course on Lean Documents, Lean Configuration and Document Control
Category:
General Manufacturing
,
Quality Management
,
Tools and techniques
,
Quality management tools
,
QA/QC
21 CFR Part 820 Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Category:
Medical Devices
,
All FDA Regulated Industry
,
QMS, ISO 13485, CAPA
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
