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Medical Solidarity
- President, CEO and Founder Medical
2013 - maintenant
solidarity an NGO active globally particularly in the USA and Sub-Saharan-Africa, multilingual, working in Francophone and Anglophone countries areas of the globe, with the mission to promoting healthcare access to the middle class and low-income families' access to high quality treatment at low cost. Ambulatory and Evacuation of patients, Short and Extended care services.
-Building solid and collaborative relationships with team members foster a productive teamwork environment, lead teams to drive the organization vision, leverage diverse views, and help develop and grow team members throughout the life of various projects.
Selected Accomplishments:
-Securing new ventures/partnerships, project extensions, including prospect lead maturation, proposal development, and closing new opportunities.
-Managing and delivering significant results that reflect strategic and creative thinking, individual initiative and follow-up abilities.
-Developing an organization vision & leading complex projects while functioning as a trusted advisor at the highest levels of public/governmental Org
-Identifying and addressing demographics health and education needs: build, maintain, and utilize networks of partner relationships;
-Communicating complex material effectively in written and oral formats to various targeted audiences, pursuit activities both internally and externally with partners and on site valuation.
-Directing and conducting quantitative and qualitative analyses of quantum complex data.
Fund-Raising/Grant Writing and Program Management/PlanningConducted board training sessions and setup KPI; Originated the establishment of goals and objectives.
Developed annual program budgets for the non-profit organization and managed a clinic focused on providing healthcare to low income families, disadvantaged women and youth. Supervised a staff of 5 Directors in 3 different countries and continents. Implemented spreadsheet analysis tools to document and illustrate financial expenses.
Public Relations: Developed press releases, speeches and grand opening media communication strategies and material
Networked with social service agencies to coordinate services for the organization: Served as a liaison with private and non-profit partnerships in PPPs
Moustapha Coulibaly Page 2
Conceived and developed a program slogan to use on all event and communications our press releases volunteer program for healthcare practitioners: Medical doctors and specialist, Nurses, Biomed and more...
Event management: Assured revenue generation from events back to targeted programs operations through adding event enhancers like specialties and outreach. Revitalized events, for example - rebranded, rescheduled, combined partner programs and concerts/sport events. Partnered with businesses and corporations on social events and programs. Utilize web presence via social medias to promote special events and programs and fundraising.
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Maquet
- Continuous Improvement Manager
ARDON
2010 - 2013
Selected Accomplishments:
* Lead and organize continuous processes improvement, business integration and ISO13485 certification, Implemented Lean 6S for higher efficiency production, repair, Demo Clinical Trials and repair areas resulting from better work flow, better usage of floor space improving OTD by 10%.
* Identified shortfalls, setup and execute strategies for short term and medium term gols to counteract and provide metrics for performance and KPI defined strategies and tactics to implement metrics in operations and leading to the development of SAP based reports which provided for clear, data-based decision-making. Value Streaming of the process resulting in fully verified manufacturing processes based upon the guidance of clearly defined by FDA registration, GMP, 510K files, UL listings, ISO certification and in significant improvement to customer satisfaction.
* Led multitude of Kaizan teams that reduced waste and improved delivered by inventory reduction $5M by eliminating off labels and complex customizations in tandem allowing for more accurate forecast incremental profit in the first 12-months by $3.6M, operating capital improved by 20%. Implemented inventory reduction/management tools based on the Inventory Quality Ratio (IQR) methodology.
* Diagnosed ``root causes'' for underperformance, addressed significant knowledge gap through state funded education grant ($60k) and provided ISO13485, 21CFR and UL/IEC training to staff of 18. Participation in project improvement teams followed. Brought alignment/cohesion of corporate, different business unit as well as sales and service units, site objectives by creating a common framework in everything from strategy to shared goals, roles/ job descriptions and competence awareness and training matrix. Overcame negative perceptions of staff & site.
* Authored an 8 step Continuous Improvement Manual; responsible for its company-wide implementation; demonstrated document's effectiveness through its use on personally led projects; resulted in a structured Root Cause Analysis and Value Streaming system which contributed to ongoing Cost Reduction efforts.
Recommended to the position to develop and implement the company's commercial business strategy within the framework of the strategic vision and annual plan; including integration of new products through acquisitions. Provide strategic and tactical execution of supply chain, demo/clinical trials, returns/repairs, engineering, regulatory, quality, strategic supply, high volume manufacturing and distribution. Assure compliance with 21CFR, cGMP/FDA/CE/MDDUL/IEC and ISO13485/9001. Accountable for development/execution of the transfer project to rationalize all Surgical products (Ventilation, Anesthesia, Surgical lights, Surgical Table, Telemedicine, Multimedia, Hybrid OR with Variop and Surgical Pendants, contributing to cost savings with a $7MM/year inventory reduction against total US sales $246 MM. Executed multiple Kaizan ``blitzes'' Factory floor transformation from ``push systems'' to ``pull systems, integrate the stock to the work cells to reduce appro downtime.
Selected Accomplishments:
* Lead and organize continuous processes improvement and ISO13485 certification, Implemented Lean 6S for higher efficiency production, repair, Demo Clinical Trials and repair areas resulting from better work flow, better usage of floor space improving OTD by 10%.
* Identified shortfalls, setup strategies to counteract and provide metrics for performance and KPI defined strategies and tactics to implement metrics in operations and leading to the development of SAP based reports which provided for clear, data-based decision-making. Value Streaming of the process resulting in fully verified manufacturing processes based upon the guidance of a clearly defined by FDA registration, GMP, 510K files, UL listings, ISO certification and significant improvement to customer satisfaction.
* Led multitude of Kaizan teams that reduced waste and improved delivered by inventory reduction $5M by eliminating off labels and complex customizations in tandem allowing for more accurate forecast incremental profit in the first 12-months by $3.6M, operating capital improved by 20%. Implemented inventory reduction/management tools based on the Inventory Quality Ratio (IQR) methodology.
* Diagnosed ``root causes'' for underperformance, addressed significant knowledge gap through state funded education grant ($60k) and provided ISO13485, 21CFR and UL/IEC training to staff of 18. Participation in project improvement teams followed. Brought alignment/cohesion of corporate, different business unit as well as sales and service units, site objectives by creating a common framework in everything from strategy to shared goals, roles/ job descriptions and competence awareness and training matrix. Overcame negative perceptions of staff & site.
* Authored an 8 step Continuous Improvement Manual; responsible for its company-wide implementation; demonstrated document's effectiveness through its use on personally led projects; resulted in a structured Root Cause Analysis and Value Streaming system which contributed to ongoing Cost Reduction efforts. Designed the user interfaces and workflows; currently maintains the system as system administrator, worked as key interface with suppliers and BU; provides user training, technical support, training materials, and facilitates change control process
* Compiles and presents metrics at Management Review ;
* Lead Auditor CI fed by CAPA process, Document review, and Database administration: Performed internal/external audits to 21 CFR 820, 21, ISO 13485, and multiple foreign standards.
* Assists in the hosting of inspections by UL/IEC, notified bodies, distribution partners, and foreign authorities.
* Coordinates the resolution of both internally and externally initiated audit findings
* Coordinates the execution of gap assessments to external standards
* Evaluation of vendors in accordance with Supplier Management process
* Assists in the management of large scale Quality Projects and risk management
* Lead auditor on all internal audits, covering GMP and ISO 13485; performs external vendor audits; hosted inspections by
FDA auditors/ 3rd party consultation groups
Moustapha Coulibaly Page 3
* Facilitate Corrective and Preventive Action Process, from initiation through closure CAPA meetings; present CAPA metrics to management
* Maintaining the effectiveness and relevance of all Standard Operating Procedures, Work Instructions, and all other controlled documentation; coordinating process of approval for document changes ;
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Maquet
- Marketing Product Manager
ARDON
2009 - 2010
Selected Accomplishments:
* Lead and organize continuous processes improvement, business integration and ISO13485 certification, Implemented Lean 6S for higher efficiency production, repair, Demo Clinical Trials and repair areas resulting from better work flow, better usage of floor space improving OTD by 10%.
* Identified shortfalls, setup and execute strategies for short term and medium term gols to counteract and provide metrics for performance and KPI defined strategies and tactics to implement metrics in operations and leading to the development of SAP based reports which provided for clear, data-based decision-making. Value Streaming of the process resulting in fully verified manufacturing processes based upon the guidance of clearly defined by FDA registration, GMP, 510K files, UL listings, ISO certification and in significant improvement to customer satisfaction.
* Led multitude of Kaizan teams that reduced waste and improved delivered by inventory reduction $5M by eliminating off labels and complex customizations in tandem allowing for more accurate forecast incremental profit in the first 12-months by $3.6M, operating capital improved by 20%. Implemented inventory reduction/management tools based on the Inventory Quality Ratio (IQR) methodology.
* Diagnosed ``root causes'' for underperformance, addressed significant knowledge gap through state funded education grant ($60k) and provided ISO13485, 21CFR and UL/IEC training to staff of 18. Participation in project improvement teams followed. Brought alignment/cohesion of corporate, different business unit as well as sales and service units, site objectives by creating a common framework in everything from strategy to shared goals, roles/ job descriptions and competence awareness and training matrix. Overcame negative perceptions of staff & site.
* Authored an 8 step Continuous Improvement Manual; responsible for its company-wide implementation; demonstrated document's effectiveness through its use on personally led projects; resulted in a structured Root Cause Analysis and Value Streaming system which contributed to ongoing Cost Reduction efforts.
Build a sales funnel, by executing targeted initiatives via trade shows, social networks, ecommerce and sales calls. Improve communication with GPOs. Develop staff core competency in key areas including: clinical application, product differentiation and positioning, Marketing, Sales, Development, Engineering quotation validation, Supply Chain control phases, and RA/QA complaint review.
Selected Accomplishments:
* Executed a second stage Product Rationalization identifying inventory problems resultant of obsolete/slow-moving product accomplishing objectives by re-focusing the Sales & Marketing efforts to ``on-label'' usage resulting in a positive contribution to the top and bottom lines
* Assigned full P&L responsibility for a product portfolio; bundled products pursuant to interaction with Sales, Marketing and End Users, formulating a new GPO strategy; sales results went from $13M in '09 to $15M by the end of 2010 or a 25% growth; today's sales are at $23M
* Led effort to develop Sales Controls simplifying PO management; reduced business costs through OPEX/COGS efforts by 15% over 24 months and dramatically improving Customer Satisfaction
* Performed Market Gap analysis on a Surgical Suite product; drove development and integration of a new capability highly desired by surgical staff and unavailable from other sources resulting in a 5% order increase in the first 12 months
* Product Management responsibilities encompassed full Concept to Commercialization functions, Promotional Materials, Training, Strategic Development and Deployment ;
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Maquet
- Operations Manager
ARDON
2008 - 2009
Selected Accomplishments:
* Lead and organize continuous processes improvement, business integration and ISO13485 certification, Implemented Lean 6S for higher efficiency production, repair, Demo Clinical Trials and repair areas resulting from better work flow, better usage of floor space improving OTD by 10%.
* Identified shortfalls, setup and execute strategies for short term and medium term gols to counteract and provide metrics for performance and KPI defined strategies and tactics to implement metrics in operations and leading to the development of SAP based reports which provided for clear, data-based decision-making. Value Streaming of the process resulting in fully verified manufacturing processes based upon the guidance of clearly defined by FDA registration, GMP, 510K files, UL listings, ISO certification and in significant improvement to customer satisfaction.
* Led multitude of Kaizan teams that reduced waste and improved delivered by inventory reduction $5M by eliminating off labels and complex customizations in tandem allowing for more accurate forecast incremental profit in the first 12-months by $3.6M, operating capital improved by 20%. Implemented inventory reduction/management tools based on the Inventory Quality Ratio (IQR) methodology.
* Diagnosed ``root causes'' for underperformance, addressed significant knowledge gap through state funded education grant ($60k) and provided ISO13485, 21CFR and UL/IEC training to staff of 18. Participation in project improvement teams followed. Brought alignment/cohesion of corporate, different business unit as well as sales and service units, site objectives by creating a common framework in everything from strategy to shared goals, roles/ job descriptions and competence awareness and training matrix. Overcame negative perceptions of staff & site.
* Authored an 8 step Continuous Improvement Manual; responsible for its company-wide implementation; demonstrated document's effectiveness through its use on personally led projects; resulted in a structured Root Cause Analysis and Value Streaming system which contributed to ongoing Cost Reduction efforts.
Hand-selected by the VP of Operations and the corporate Executive VP in Europe to transferred from the corporate office in France to the US to Support to the U.S. organization to play an instrumental role in identifying and setting a new course of action directed at rapid top and bottom line growth. Reported to the Vice President of Operations advice on key function to implement in the Surgical Work places integration to Maquet Critical Care member of the high performance team share accountability for the success of the US business unit a team of 140+. Tasked to overcome obstacles preventing financial goal achievement. Accountable for U.S. manufacturing integration for engineering and project management to support existing business units in Europe, transfers production line fron Charleston, SC to New Jersey and new product commercialization and distribution integration. Active in the strategic plan and execution of the organization restructuring. Assure improvement actions, avoid adverse sales, customer, regulatory or product quality issues. Responsible for SIO strategy, training, internal, including the activities related to the supply chain and logistic teams between the US and our factories in Europe, local manufacturing, distribution, shipping and receiving functions. As such, develop continuous improvement activities to be implemented concurrently in Sales, Sales Operations, Service, domestic Supply Chain and Regulatory. Member and sponsor of a high performance team in the Field Service/Sales, Logistics, Order Administration, RA/QA, Contracts, Sales Operations, Repair, Distribution, Sales Engineering, Installation and Technical Support. Address outstanding FDA actions.
Selected Accomplishments:
* Assigned to a challenge of a poorly managed integration which lead to a multitude of "non-compliant/non-Validated" component issues by providing training on the importance of V&V, re-validation of product and Value Streaming of the process resulting in fully verified manufacturing processes based upon the guidance of a clearly defined ISO certification and significant improvement to customer satisfaction.
* Co-leading the transfer of a $76M production line from Charleston, SC to Boundbrook, NJ and later to Wayne, NJ
* Identified shortfalls, setup strategies to counteract and provide measuring metrics for performance of processes and requirements to align needed actions in order to improve efficiency by tracking KPI.
* Identified significant inventory problems (e.g. obsolete, slow-moving) by re-focusing sales & marketing efforts to "on-label" usage which resulted in positive contribution to both the top and bottom line.
* Championed the review of our rules of engagement, From customer quote- funnel-Factory order- backlog management-custom-customer delivery/installation. Build a training program with the Training Department. Liaison to the SW factories. Assist Marketing in Product launch and Sales training for NSM, AORN, NTI, and MEDICA to name a few. Rationalized our CSU (Booms) $13M USD annual sales to help reduce waste and minimize nonconformance.
* Organize training related to our products as well as UL. Organize, motivate and assist operations on day- to- day functions.
Maquet/Getinge, Ardon, France
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Maquet
- Client support Engineer
ARDON
2005 - 2008
Selected Accomplishments:
* Lead and organize continuous processes improvement, business integration and ISO13485 certification, Implemented Lean 6S for higher efficiency production, repair, Demo Clinical Trials and repair areas resulting from better work flow, better usage of floor space improving OTD by 10%.
* Identified shortfalls, setup and execute strategies for short term and medium term gols to counteract and provide metrics for performance and KPI defined strategies and tactics to implement metrics in operations and leading to the development of SAP based reports which provided for clear, data-based decision-making. Value Streaming of the process resulting in fully verified manufacturing processes based upon the guidance of clearly defined by FDA registration, GMP, 510K files, UL listings, ISO certification and in significant improvement to customer satisfaction.
* Led multitude of Kaizan teams that reduced waste and improved delivered by inventory reduction $5M by eliminating off labels and complex customizations in tandem allowing for more accurate forecast incremental profit in the first 12-months by $3.6M, operating capital improved by 20%. Implemented inventory reduction/management tools based on the Inventory Quality Ratio (IQR) methodology.
* Diagnosed ``root causes'' for underperformance, addressed significant knowledge gap through state funded education grant ($60k) and provided ISO13485, 21CFR and UL/IEC training to staff of 18. Participation in project improvement teams followed. Brought alignment/cohesion of corporate, different business unit as well as sales and service units, site objectives by creating a common framework in everything from strategy to shared goals, roles/ job descriptions and competence awareness and training matrix. Overcame negative perceptions of staff & site.
* Authored an 8 step Continuous Improvement Manual; responsible for its company-wide implementation; demonstrated document's effectiveness through its use on personally led projects; resulted in a structured Root Cause Analysis and Value Streaming system which contributed to ongoing Cost Reduction efforts.
International client support Ireland, Australia and New Zealand.
* Responsible for Risk Assessment of NPD both up and down stream for Compliance to 21CFR, FDA/510K, CE/MDD, UL/IEC and other notifying bodies resulting in compliance of our Complaint Handling System (C&R/MDR & CAPA) in the US, EU & Australia
* Assists in the hosting of inspections by FDA, notified bodies, distribution partners, and foreign authorities, presubmission, third party eavaluation selection, conformance statement, preliminary questions and risk analysis, design control DMR, validation and revalidation, acceptance criterias, labeling and or relabeling, evaluation possible NFJ, submition of NFJ, Clinical tials, tradeshow dispalay of pre approved devices during submission (pending 510K), 510K submission with committee, 510K acceptance and clearance, and post 510K submission and market introduction...Post market management during the life of the product to obselescances of class I, II and III devices
* Responsible for the processing of BU Bisiness Unit side (factory) of Product Complaints and international MDRs filling and handling in MAGIC; this includes MDR filing, customer/Sales and Service Unit communications, and file maintenance; performed analysis of complaint data for presentation to management; proctored Biweekly complaint meetings to review all open complaints
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* Assisted in validation of Part 11 database (Magic software system); designed the user interfaces and workflows, worked as key interface with SSUs; provides user training, technical support, training materials, and facilitates change control process
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* Assisted in the preparation and administration of multiple correction and removals
* Managed a Warranty budget of +1M Euros in the US, EU & Australia; responsible for training and indirect management of 80+ Field Service people. ;
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ImageWorks AFP Imaging
- Lead International Client Support
2000 - 2004
ImageWorks AFP Imaging/Dent-x, Yoshida, NewTom (Cone Beam) in
International client support
* Drove improved customer satisfaction resulting in improved revenue and profits; managed staff of 4 directs and 50 indirect field Engineers; Part of the development team of innovative Medical imaging devices conventional, digital and nuclear. Member of the 510 K preparation validation testing and clinical trail of EVA and Panorex...
* Career path growth resulted in Management responsibility for the Tech Support Team that serviced and maintained imaging equipment for X-Ray Digital Imaging, Mammography, Intraoral, Panoramic, Cephalometric & Angiographic systems ;
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My Custom Computers and Network
- President
1998 - 2000
My custom Computers, Servers and Network, White Plains, NY Owner President Start-up Company,
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Texas Instruments
- Operator automated production
Villeneuve-Loubet
1997 - 1998
white room (clean room) operator automated production line of vehicles ECU
