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Orlando Banos
President & CEO
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With 23 plus years of experience in in quality / assurance, manufacturing, engineering, and product development with a heavy focus on quality management to ensure that products (and services) are developed (designed), manufactured, tested, and delivered according to established procedures that will assure compliance and continuous improvement. High level of personal and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction. Creative problem solving and troubleshooting skills complemented by a meticulous and creative thinking ability focused on detail with a “can do” attitude.

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Experience

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  • Founded Virtue Quality Consultants, Inc., a firm that provides Independent quality and regulatory consulting services for biotech, medical devices, pharmaceutical, and consumer products specializing in remediation efforts of quality systems associated with corrections and improvements of a Quality Management System.

  • Acted as a remediation CAPA Coach / Production & Process Control SME Consultant under an FDA warning letter for Cook Medical Inc. that was later lifted – Represented by Redbock on a C2C.

  • Performed various correction activities acting as a Sr. Quality Consultant for Zimmer Biomet that included revising written instructions, revamping the management control, document and change control, quality auditing, purchasing control, CAPA, risk management, design controls, production and process control operations and UDI System – Represented by Goode Compliance International on a C2C.

  • Represented the function of a Sr. Manager, Technical Quality for Kimberly-Clark Healthcare were activities included developing, implementing, and maintaining quality systems to support design control processes & activities in the manufacturing of electrosurgical generators, electrical hand-held devices, and electrical accessories.

  • Represented the function of Manager, Technical Quality for Kimberly-Clark Professional were activities included developing, implementing, and maintaining quality systems to support a broad range of industrial, cleanroom, scientific, and safety products.

  • As Sr. Design Quality Engineer led efforts to ensure and maintain design control activities & deliverables to support the best manufacturing practices for a broad range spine products and technologies to treat a variety of neurological, orthopaedic, and spinal conditions.

  • Acted as the subject matter expert in all quality and regulatory matters of operations (milling, blending, WFI, UPW, CIP, SIP, etc), for Becton Dickinson to support an animal-free hydrolysates and liquid and powder cell culture media formulations.

  • As Sr. Quality Assurance Engineer led efforts in maintaining quality assurance systems and activities for the design and manufacturing of Orthopaedic Medical Devices such as arthroscopy pumps, ablation probes, handheld shavers, and various non-electrical products.

  • As Sr. Manufacturing Engineer responsible for the implementation and maintenance of multiple products lines in the manufacturing of guidewires to reduce variability, reduce labor content, increase yields, and streamline production.

  • Represented the function of Project Manager / NPD Engineer were activities included managing an R&D lab associated with the designing, testing, and delivery of pharmaceutical drug coatings (spray coatings & flow coatings), bioassays, new equipment, process, and methods to manufacturing. 

  • Cordis Corporation, a Johnson & Johnson Company-Special Recognition Team Excellence Award for the innovation and implementation procedure & method that involved the removal of heparin coating on stents. “Revenue savings 30-40 million in sales”.

  • Cordis Corporation, a Johnson & Johnson Company-Special Recognition Bonus for Standards of Leadership Award in Recognition of Distinguished Achievement (2001). “Total savings of 3-4 million”.

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Positions Held

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  • Virtue Quality Consultants, Inc. - President & CEO

  • CAPA Coach and P&PC SME - Cook Medical via C2C Redbock

  • Sr. Quality Consultants - Zimmer Biomet via C2C GCI

  • Sr. Manager, Technical Quality - Kimberly-Clark Healthcare

  • Manager, Technical Quality - Kimberly-Clark Professional

  • Project Manager / NPD Engineer - Cordis Corporation

 

Education

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  • Bachelor of Arts in Analytical Organic Chemistry - Florida International University

  • Master of Science in Engineering Management - Florida International University

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Continuing Education

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  • Six Sigma Certified

  • Process Validation Certified and Coach

  • Risk Management SME

  • Project Management Training

  • Certified ISO 13485 Lead Auditor

  • Statistical Methods for QE Certification

  • Project Management Training

  • MDSAP Training

  • SaMD Training

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