Victor Mbb

Victor Mbb

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Quality Director, New Product Development and Product Lifecycle Management
Florida, United States

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  • Bausch Lomb
    Global Program Manager
    Bausch Lomb
    Jan 2024 - Current (2 years 7 months)
    Lead enterprise transformation initiatives focused on modernizing quality infrastructure and improving cross-functional collaboration across R&D, manufacturing, and regulatory operations.
  • Danaher Corporation
    Director Quality, Development and Product Lifecycle Management
    Danaher Corporation
    Mar 2020 - Current (6 years 5 months)
    The Director of Design Quality and Lifecycle Management plays a critical role in ensuring the successful development, launch, and continuous improvement of high-quality, reliable, and regulatory-compliant products. Business Leadership Attributes Strategic Leadership: Lead and manage the Design Quality (Design Assurance) functional group, ensuring seamless collaboration with product development, sustaining engineering, and other business functions to drive the timely and efficient launch of new products that comply with global regulatory standards and exceed customer expectations. Post-Market Quality & Continuous Improvement: Serve as the Business Unit Quality Lead for post-market quality initiatives, both direct and indirect, to enhance per
  • Danaher Corporation
    Lead Designer
    Danaher Corporation
    Jan 2020 - Jan 2024 (4 years 1 month)
    Directed product lifecycle quality strategy supporting R&D, manufacturing, and post-market surveillance for global diagnostic products.
  • Sprig Oral Health Technologies Inc
    Program Director - Quality System Remediation - Principal Consultant
    Sprig Oral Health Technologies Inc
    Jan 2019 - Mar 2019 (3 months)
    CAPA closure, Root Cause analysis, DMAIC process management, notified body interaction for issue resolution, Design History File remediation, MDSAP / MDR Gap remediation and preparation, Clinical Evaluation Report CER development, editing, and review. Technical Documentation File updates / Remediation.
  • SmileDirectClub
    Principal Consultant - Quality Systems Gap Assessment
    SmileDirectClub
    Oct 2018 - Dec 2018 (3 months)
    Quality System gap assessment, remediation, and development - Quality System Element: 820.80 Rec. insp. In proc, fin dev accept, 820.86 Acceptance Status 820.90 nonconforming. 1. Inspection Sheets/ forms for inspection incoming Mtl's to resolve failure to document the results. Develop a method of capturing inspection results. 2. Work instructions for in final/process inspections. Develop overarching SOP of in-process / final inspection. 3. Nonconforming procedure. Develop a nonconforming / scrap procedure for internally manufactured items 4. Rework SOP Development and SOP for governing rework 5. Complaints and Post Market Surveillance SOP development with cross-functional groups i.e. Customer Service / CRM, IT and Quality Manage
  • Mindshare Medical
    Director of QA & RA
    Mindshare Medical
    Jan 2018 - Mar 2020 (2 years 3 months)
    Driving progress in healthcare research and diagnostics through analytics, accurate and efficient imaging technologies. Specialties: medical imaging; software development; cognitive neuroscience and neuropathology; systems integration; microscopy; stereology; big data. - Application of Software as a Medical Device(SaMD), (AI) Artificial Intelligence Lung nodule management. RevealAI-Lung provides a Malignancy Similarity Index (mSI) from lung CT scans that aids risk assessment. Graphs are provided that help interpret how lung nodules from the current patient relate to confirmed malignant or benign nodules. Utilizing the NLST - National Lung Study Trial as a Machine Learning database. EU Tech File maintenance, FDA 510K submission process, MDS
  • Wichita State University
    Senior Project Student Advisor - Mentor Volunteer
    Wichita State University
    Oct 2017 - Jul 2022 (4 years 10 months)
    Industrial Engineering student mentor for Senior Project execution and implementation. Project scope, planning, advisement, budget estimation, and applied technical theory. Area of activity - Contamination Control compliance at Pfizer Location McPherson KS. Wichita State contact - Cindi Mason (316) 978-5915 Assistant Teaching Professor | Undergraduate Coordinator Industrial, Systems, & Manufacturing Engineering Wichita State University
  • Pfizer
    Program Manager / Consultant
    Pfizer
    Oct 2017 - Oct 2018 (1 year 1 month)
    Contamination control project/deliverables which have been identified by a cross functional team to be high priority will be implemented for mitigation of the risk for cross-contamination to the CNC Area by product, material and personnel movement. Background Annual Contamination Control Assessments identified high priority areas for improvement Non-Particulate Generating Materials are Always Preferred A. Monitor/Minimize/Eliminate Wooden Pallets and Corrugate B. Pack Areas Segregated from Fill Area Personnel Movement through Facility must have Controls A. Stage I Gowning Strategy to limit wearing of Blue Gowning in Front Areas of Plant
  • Mindshare Medical
    Director Quality Regulatory Affairs
    Mindshare Medical
    Jan 2017 - Jan 2020 (3 years 1 month)
    Led compliance and product development support for AI-driven diagnostic imaging platforms.
  • Fresenius Medical Care North America
    Senior Manager, Regulatory Affairs Device Change Control
    Fresenius Medical Care North America
    Nov 2016 - Nov 2017 (1 year 1 month)
    Supports FMCNA's new medical device and marketed product development. Investigates and assesses changes to all existing products in compliance with applicable international and US federal laws. Provides leadership to regulatory professionals engaged in evaluation of changes. Collaborates with the Corporate Regulatory Affairs team to develop device-related regulatory submissions as needed. Formulates regulatory policies /programs. DUTIES AND RESPONSIBILITIES: Manages and oversees the assessment of design changes for all existing products. Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results. Provides leadership, coaching, and development plan
  • O
    Vice President of QA & RA (Staff Augmentation) Oriel Stat-A-Matrix - Prinicpal Consultant
    Oriel STAT A MATRIX
    Jan 2016 - Nov 2016 (11 months)
    Interim Staff Augmentation for provider of contract manufacturing and related services to specification developers of finished medical devices or medical device component parts and assemblies. Key products included Combination products- Auto Injectors – drug delivery / device accessories - endoscopy, control console for breast biopsy system and Supply Chain elements include – Sterilizers, instrument machining, electronic assembly, injection molding, precision machining, sheet metal fabrication / assembly and automation providers. Recruited to drive the implementation of the Quality Management System and ensure alignment and integration with the Product Life-Cycle Management expected from regulated industry environments. Gap assessed, prog
  • Smiths Medical
    Design Control Remediation Program / Project Manager - Prinicpal Consultant Via Oriel Stat-A-Matrix
    Smiths Medical
    Jul 2015 - Nov 2016 (1 year 5 months)
    F-50 Level 1 Normothermic I.V. Fluid Administration Set Design Verification / Validation testing. FMEA (D & P) review with clinical effects (UFMEA) - development, update. Control Plans, Design Inputs / Outputs, Processes utilized - Sonic Welding, Solvent bonding, Plastic tubing extrusion, Plastic injection molding, UV bonding methods, Tyvek package sealing and hand assembly. Product development of numerous models. Test Method Validation protocol - development and execution. Validation method guideline updates. Shop floor employee training and certifications. Updated visual aids for assembly activity. Planning - Validation Determination / Rational (Attribute, Variable, Destructive Test Methods) Validation Strategy (VS) – Reference associ
  • Genetech
    Senior Consultant / Program Director - Prinicpal Consultant
    Genetech
    Aug 2014 - Nov 2016 (2 years 4 months)
    Oriel STAT A MATRIX helps medical device, pharmaceutical, and biotechnology manufacturers achieve compliance with global regulations while improving business processes, thus reducing both cost and risk. Our consultant team – Life Sciences industry experts and former FDA professionals – will ensure that your RA and QA systems are optimized for compliance and effectiveness. We can also help organizations develop in-house expertise with our full range of Life Sciences RA/QA training courses. Since 1968, Oriel STAT A MATRIX has helped organizations improve performance, achieve regulatory compliance, and secure sustainable success. Through training, consulting, and professional coaching, our strategically driven approach to applying Lean Six
  • Midmark Corporation
    Quality System Remediation Program Director - Prinicpal Consultant Via Oriel Stat-A-Matrix
    Midmark Corporation
    Aug 2014 - Jul 2015 (1 year)
    Regulatory Compliance Program Developer / Consultant - Business process re-engineering, CAPA, RG (Returned Goods), Post Market Surveillance, Investigations, Complaints - Retrospective Error Code review, PRE - Potential Reportable Events, MDR's - Medical Device Reportable, Recalls / HHE's (Health Hazard Evaluations), Interim Control Plan Developer, Internal and Supplier Auditor / Trainer - ISO 13485, Device History Record (DHR) / Device Master Record (DMR) Retrospective review and analysis. Purchasing Controls - Supply Chain development - Lean & Six Sigma - Quality, Capacity, Cost, and Delivery.
  • Amgen
    Design Control Program Manager / Consultant
    Amgen
    Feb 2014 - Aug 2014 (7 months)
    Design history file (DHF) remediation for FDA regulations CFR 210, 211, 820, ISO 13485 and ISO 14971 standards alignment and compliance. Led gap analysis and remediation for, SOPs, DHF, Design Input and Output docs., Design Verification, and Design Validation docs., Process validation docs. and Vendor specifications. Preparation for FDA review, including mitigation rationale and presentation strategy. Collaboration with product Subject Matter Experts (SME's) regarding DOORS software development and application. Supply chain management of purchased component and product specifications via Certificates of Analysis (CofA) and Certificates of Conformity (CofC). SAP virtual Bill of Material reviews. Developed test plans for combination produc
  • Johnson Johnson Depuy Synthes
    Work Stream Program Manager - Prinicpal Consultant Via Oriel Stat-A-Matrix
    Johnson Johnson Depuy Synthes
    Nov 2013 - Feb 2014 (4 months)
    Johnson& Johnson – Depuy / Synthes (West Chester, PA) November 2013 March 2014 – Quality System work stream – Production and Process Controls Project and Program Management. Remediation, Implementation and Legacy Review tracker updates, Internal audits for quality systems deficiencies, headcount and budget reporting with spend utilization.
  • Roche Genentech
    Global Quality Business OPEX Project Manager - Prinicpal Consultant Via Oriel Stat-A-Matrix
    Roche Genentech
    Jul 2013 - Nov 2013 (5 months)
    http://www.gene.com/ http://www.gazyva.com/hcp - Designated Breakthrough Technology by the FDA, 1 st drug given the designation, for Leukemia - Design For Six Sigma Business Process Excellence - Continuous improvement related to operational value streams and strategic program execution. Business process intergration of quality system support tools Trackwise, Condor. Metrics development for enterprise scorecard development. SOP writing and change control execution, Quality system audit follow up CAPA's execution, Business process FMEA and risk management program development.
  • SENO Medical Instruments
    Regulatory Submission Program Manager Via Oriel Stat-A-Matrix
    SENO Medical Instruments
    May 2013 - Aug 2013 (4 months)
    http://www.senomedical.com http://www.bizjournals.com/sanantonio/blog/2014/02/seno-medical-instruments-raises-nearly-35-million.html?page=all Pre Market Approval (PMA) process document review, creation and submission. Laser and Ultrasound breast tissue scanning device 510K submission. DRD - device requirements documentation, Software FMEA, System DFMEA, PFMEA, System Hazard Analysis, ISO 14971 compliance, ImagioTM Breast Imaging System, Capital equiment medical device. System Hazard Analysis
  • Hospira
    Senior Program Manager - Consultant Via Oriel Stat-A-Matrix
    Hospira
    Aug 2012 - May 2013 (10 months)
    CAPA Effectiveness Metrics, HHE administration related to complaint event codes, PPM defect rates, FDA Risk Management Files Remediation - Hazard Analysis, DFMEA, PFMEA / Control Plan, DOORS Software upload. Consent Decree, FDA Warning Letter, 483. Program Manager
  • Novartis
    Project Manager - Consultant - Lochmond / Quantic
    Novartis
    Mar 2012 - Aug 2012 (6 months)
    GxP Compliance auditing, Internal Auditing, Production Line Start Up - Excedrin, Theraflu, and Interceptor. Project Management, training - Compliance, Validation- Equipment: Compounders, Mixers, CIP, URS, Master Validation Plans, Software Validation, Clean and Hold, Pill forming, Lean Process flow, Root Cause analysis, CAPA, Complaints. Third party remediation, Procedure and Policy development / deployment - training
  • St Jude Medical
    Program Manager - CAPA / MDR remediation Prinicpal Consultant Via Oriel Stat-A-Matrix
    St Jude Medical
    Oct 2011 - Mar 2012 (6 months)
    CAPA system overhaul, Trackwise implementation and deployment, IEC 60601 standards implementation across product lines, DFMEA / PFMEA development. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm170224.htm
  • O
    Senior Program Director
    ORIEL STATAMATRIX
    Jan 2011 - Jan 2016 (5 years 1 month)
    Advised global medical device and pharmaceutical organizations on quality systems, operational excellence, and regulatory readiness.
  • QPharma Inc
    Senior Program Manager
    QPharma Inc
    Jan 2011 - Jan 2012 (1 year 1 month)
    Quality Systems ISO 13485 consultant / Six Sigma Trainer / Lean Practioner
  • BIOMET
    DIrector of Quality Assurance / Reg. Affairs / Clinical Affairs
    BIOMET
    Jun 2010 - Jul 2011 (1 year 2 months)
    Clinical Affairs / Regulatory Affairs / Quality Assurance: Day to day programs administration of a 420MM medical device manufacture. New product and distributor product support for Soft Tissue to bone fixation devices, knee and hip implantable products, biologics and pharma product development. Multisite responsibility for Ontario, CA – Fairlawn NJ – Warsaw IN and supply chain support - insourcing / outsourcing to supply chain providers / contract manufactures - China.
  • Q
    Chief Operating Officer
    QualRx Inc
    Feb 2009 - Mar 2010 (1 year 2 months)
    We are the nation's first minority and veteran-owned professional services firm dedicated to providing hospitals, health systems, and government agencies of all sizes with solutions in key health care areas including clinical and health system performance improvement, infection prevention and control, data management, health care information technology, and health law. Our mission is to help our private clients and government agencies develop and "hard wire" human processes and technological systems to improve patient safety, quality, and outcomes. We make the right thing to do the easy thing to do.™
  • Aptuit Mersana Theraputics
    Senior Consultant - Drug development XMT 1107 Via BioBridges
    Aptuit Mersana Theraputics
    Jan 2009 - Jan 2010 (1 year 1 month)
    http://mersana.com/ Drug Synthesis- XMT - 1107 for small batch and scale up production (Aptuit Labs - Contract Manufacture Kansas City). Lyophilization - Freeze drying (Glasgow Scotland). Process definition & Characterization New Drug Application (NDA) - FDA
  • Insulet Corporation
    Senior Auditor / Consultant
    Insulet Corporation
    Jan 2009
    Global Harmonization of Quality auditing standards. Gap assessment and remediation. http://en.wikipedia.org/wiki/Global_Harmonization_Task_Force
  • Stryker Orthopaedics
    Consultant
    Stryker Orthopaedics
    Jan 2008 - Jan 2009 (1 year 1 month)
    Process Validation - IQ / OQ /PQ - Machining equipment / Cleaning validation. Master Validation plan development. Metrics Reporting Project Management - Mahwah NJ
  • Oxford international
    Consultant
    Oxford international
    Jan 2006 - Jan 2007 (1 year 1 month)
    General Manufacturing consulting - Lean / Risk Management / Validation
  • Kaiser Permanente
    Consultant
    Kaiser Permanente
    Jan 2005 - Jan 2006 (1 year 1 month)
    PFMEA development / Process mapping - As Is / Should - Be
  • Parexel
    Senior Consultant
    Parexel
    Jan 2004 - Jan 2008 (4 years 1 month)
    Six Sigma Program Management / Project Management / DFSS for drug development - Astra Zeneca / Valedant Pharmaceuticals / Merck / Phillips QMS remediation
  • Flowserve
    Director Of Continous Improvement
    Flowserve
    Jan 2004 - Jan 2006 (2 years 1 month)
    Six Sigma Training of Green Belts / Black Belts in the Americas - USA / Mexico / Canada / Brazil / Venezuela. Alignment of projects to Hoshin Planning efforts of corporate management. Project backlog, divisional metrics for Pump, Valves and Seals divisions. Reported to Divisional presidents and VPs of Operations.
  • Chase
    VP of Account Services Risk Management
    Chase
    Jan 2004 - Jan 2005 (1 year 1 month)
    Default Accounting for Checking / Debit Card Customer Servicing (Stockton, CA) / Default Accounting Mortgages / Forced Place Insurance (Melbourne FL) / Home Mortgage Document Warehousing (Houston)
  • Weyerhaeuser
    Lean / Six Sigma Director - Americas
    Weyerhaeuser
    Jan 2004 - Jan 2005 (1 year 1 month)
    Develop lumber yards and customer service areas to incorporate LEAN Thinking - supermarkets / kitting / Heijunka Boards / delivery metrics / Safety events, KAIZEN events
  • BioBridges
    Senior Program Consultant
    BioBridges
    Jan 2003 - Jan 2010 (7 years 1 month)
    http://www.biobridges.com/ Clinical Research- Bio Statistics, Quality Systems Consulting and Project Management via PAREXEL and Insulet
  • Parexel
    Senior Consultant
    Parexel
    Jan 2003 - Jan 2007 (4 years 1 month)
    Process improvement (Six Sigma / Lean) NDA/ IND (New Drug Application / Investigational New Drug) Project Manager (Retigabine, Subutex / Subxone) – Team coordination and budget adherence, developed NDA quality process control plan. Adjusted resources for medical writing with subject matter expert. Coordinated statistical package analysis with subject matter expert. Implemented project timeline, engagement plan, status reporting, deliverables matrix, issues log, and budget tracking spreadsheet. Participated in FDA pre NDA and subsequent NDA meetings.
  • D
    Six Sigma Master Black Belt
    Delphi Packard Electric Systems Company Ltd
    Jan 2001 - Jan 2005 (4 years 1 month)
    http://delphi.com/ Six Sigma Program development
  • Ford Motor Company
    Divisional Lean Coach
    Ford Motor Company
    Jan 2001 - Jan 2003 (2 years 1 month)
    Stamping and Fabrication LEAN Transformation - Value Stream Mapping, Kanban installation, Synchronous Material Flow, Pull system development with supply chain management, ASN - Advance Shipping Notice, Line side delivery, Heijunka Board development, Kaizen event coordination, "Learning to See", Wherenet development RFID. Chicago Heights / Chicago, IL - Buffalo, NY - Wayne, MI - Louisville, KY, Dearborn, MI - Mazda - Hiroshima, Woodhaven, MI
  • Owens Corning
    Six Sigma Master Black Belt
    Owens Corning
    Jan 1998 - Jan 2000 (2 years 1 month)
    Divisional Master Black Belt Building products- Shingle, Asphalt, Culture Stone and Vinyl siding - Mentoring 30 Green Belts , 10 Black Belts on process improvements related to site revenue generation across 27 facilities nationwide.
  • Q
    Sensei Consulting
    QualRx Inc
    Feb 1997 - Jan 2002 (5 years)
    Senior Quality Director / Sigma Master Black Belt, Manufacturing Engineering Manager, Senior Project Manager, Business transfer and Outsourcing Six / Consultant and Process Control expert experienced in World Class processing techniques- Benchmarking - Voice of the Customer – Advocate for transactional computer applications CAPA, Policy / Procedure writing, PMA evaluator for Risk Management Controls / Design Controls within a FDA regulated environment for Class 3 devices including cardio stent, orthopedic implants and patient monitoring devices. Compilation and advisement on (21 CFR 814.3) including supplements. ISO/QS 9000 Lead Assessor, Quality System assessment for new medical device product development. Document review, (work instructi
  • S
    CEO
    Sensei Consulting
    Jan 1997 - Jan 2009 (12 years 1 month)
    Program Management for Corporate Integrity Agreement (CIA) with FDA remediation regarding CAPA, Complaints, 483 and Warning Letters.
  • S
    President / CEO
    Sensei Consulting
    Aug 1996 - Nov 2008 (12 years 4 months)
    Process Improvement - Service, transactional, manufacturing and supply chain via Lean Processing and Six Sigma Techniques. Industries - Banking and Finance - Comerica Bank, WAMU / Med Device / Pharma - Boston Scientific, Glaxo Smith Kline, Reckitt Benckiser, Stryker Ortho, Zimmer Ortho, Medtronic, Sanofi Aventis, Merck, Cleveland Clinic, J & J, St Jude, Kyphon, Spectranetics, GEMS -GE Medical Systems, Volcano / Automotive Tier One suppliers/ Aerospace framing and sub-assembly - Boeing and Lockheed Martin / Govt HUD and DOD
  • Toyota
    Project Manager
    Toyota
    Jan 1996 - Jan 2001 (5 years 1 month)
    Lean techniques implementation at NUMMI . SMED / Kaizen events coordinator / Heijunka / Kanban / Jidoka. Employee training / skills assessment.
  • Harman International
    Manufacturing Engineer
    Harman International
    Jan 1992 - Jan 1994 (2 years 1 month)
    Automotive tier one supplier, PFMEA / DFMEA development, tooling & Fixturing for assembly line manufacturing , SPC, Product Launch, Lean Program intergration, QS 9000, Electrical assembly
Education verified_user 0% verified
  • Trine University
    Master's degree, Biomedical Engineering
    Trine University
    Jan 2010 - Jan 2012 (2 years 1 month)
  • Case Western Reserve University
    B.S, Industrial Engineering
    Case Western Reserve University
    Jan 1982 - Jan 1986 (4 years 1 month)
    Football and Wrestling
  • Benedictine High School
    High School Diploma, College Prep
    Benedictine High School
    Jan 1978 - Jan 1982 (4 years 1 month)
  • Trine University
    Master of Science, Organizational Leadership
    Trine University
    Concentration: Biomedical Engineering & Regulatory Affairs
  • Case Western Reserve University
    Bachelor of Science, Industrial Engineering
    Case Western Reserve University
Projects (professional or personal) verified_user 0% verified
  • P
    PMA for Ultrasonic / Laser imaging system.
    Jul 2013 - Current (13 years 1 month)
    http://www.senomedical.com http://www.bizjournals.com/sanantonio/blog/2014/02/seno-medical-instruments-raises-nearly-35-million.html?page=all Pre Market Approval (PMA) process document review, creation and submission. Laser and Ultrasound breast tissue scanning device 510K submission. DRD - device requirements documentation, Software FMEA, System DFMEA, PFMEA, System Hazard Analysis, ISO 14971 compliance, ImagioTM Breast Imaging System, Capital equiment medical device. System Hazard Analysis
  • R
    Risk Management ISO 14971 PFMEA / Control Plan Updates
    Mar 2013 - Current (13 years 5 months)
    At three sites for Hospira Consumable manufactured products, San Jose - Costa Rica, Santo Domingo - Dominican Republic and Lake Forest, IL, created PFMEA's, DFMEA's, DOORS (Dynamic Object Oriented Requirements) documentation and Hazard Analysis (HHE) documentation as part of FDA letter to industry initiative regarding infusion pump manufacturing and risk management inherit to design and manufacturing. Lead a team of 5 contractors evaluating product platforms.
  • C
    CAPA Effectiveness Measures at Hospira
    Oct 2012 - Current (13 years 10 months)
    Program manager for retrospective study on CAPA effectiveness for Hospira Infusion pumps in Lake Forest IL and San Jose CA. A review of defect codes, timely resolution of product problem based on closed CAPA and solution implementation. Response variables include complaint occurence rates, change control implementation, HHE - Health Hazard Evaluation process completion and execution.
  • N
    Novartis OTC Lincoln NE - Excedrin / Interceptor Remediation
    Jan 2012 - Current (14 years 7 months)
    Manufacturing GMP auditing, Validation (Equipment and Process) , Compliance and Production readiness (Pharma Processing / Packaging), Lean / Six Sigma Project and Program management, Operational Dashboard Development, Value Stream Mapping, and Project Management, Products - Excedrin, Sentinel Heartworm (Animal Health)
  • Q
    Qual - Rx / Kaiser Permanente - Performance Improvement Initiative Hospital Healthcare Model
    Dec 2008 - Current (17 years 8 months)
    The survey tool will assess the stages of KP’s Performance Improvement (PI) Initiative implementation Results from the initial survey provides a baseline for evaluating KP's PI progress during future assessments Personnel, ranging from executive leadership to front-line staff, will provide information for the assessment to reflect the entire organizational Survey results help to direct change management efforts in specific areas Criteria for the assessment are organized by the six areas of high performance: Leadership Learning Systems & Processes Measurement Capacity & Sustainment Culture
Awards verified_user 0% verified
  • I
    Master Black Belt
    Issued by Six Sigma Qualtec
    Divisional Master Black Belt for 10 sites for Owen Corning. Training / Mentoring multiple waves of Yellow, Green and Black Belts. Champion training and project backlog development.
Publications verified_user 0% verified
  • J
    Proposed Changes and Potential Effects on the FDA / 510(k) submission and evaluation process
    Jun
    Proposed CDRH (Center for Devices and Radiological Health) evaluation process changes and effects related to these changes. Risk managment of said changes and the need to understand failure modes of this managment process.
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