Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Multilingual professional project manager with over 35 years of consulting experience in North America, Latin America, Europe, and Asia focused on supply chain issues with expertise in materials, manufacturing, purchasing, operations, logistics, warehousing, distribution, and regulatory compliance. Highly credentialed with hands-on experience working in medical device, pharmaceutical, telecommunication, aerospace, and defense manufacturing industries. Background in drip/infusion bag, IV set, pain management infusion pump, suction pump, temperature probe, syringe with and without needle, catheter, endotracheal tube, and blood separation (blood transfusion bags, plasma, and platelets) medical device products, and liquid and solid dose drug products.

CORE COMPETENCIES

  • Project Management/Project Plans
  • Project Leadership/Project Facilitation
  • Supply Chain Procurement/Materials Planning
  • Packaging/Transportation/ Logistics
  • Inventory/Warehouse Management
  • Distribution Resource Planning
  • Process Improvement/Six Sigma
  • Lean Manufacturing
  • Kaizen/Kanban/SMED Techniques/5S Methods
  • FDA 21 CFR Parts 820/210/211
  • ISO 9001/FDA Remediation/Gap Analysis
  • Internal/Supplier Auditing
  • Supplier Qualification and Selection
  • Procedural Development/Work Instructions
  • Corrective and Preventative Action (CAPA)
  • Change Management/Change Control

SELECTED ACCOMPLISHMENTS

  • Managed various packaging efforts, including development of packaging specifications, for drugs and other controlled substances in vials, capsules, and caplets (e.g. morphine, profocal, etc.), drip/infusion bags, IV and IV sets of saline, whole blood transfusion bags, plasma, and platelets
  • Coordinated efforts related to packaging changes with various interdepartmental subject matter experts, including R&D, lab, QA/RA, and medical groups
  • Participated in development of packaging related to vibration testing, shock/impact testing, environmental climate control testing, and degradation testing related to pain management infusion pumps and suction pumps, syringes with and without needles, endotracheal tubes, temperature probes, and catheters
  • Reviewed and approved packaging changes for pharmaceutical and medical device products as member of engineering control review boards
  • Developed and implemented Standard Operating Practices (SOP’s) related to procurement, shipping, receiving, and packaging processes for various pharmaceutical and medical device products
  • Relocated facility to Juarez, Mexico generating $5M in annual reoccurring savings
  • Coordinated and facilitated physical move of companies from one location on time and within budget, completing necessary testing and validation of all equipment without issues
  • Implemented same-day pick, pack, and ship process by negotiating discount agreement guaranteeing next-day delivery, which generated $500K in savings
  • Facilitated operational strategies for all supply chain management and transportation for $4.5B holding company with oversight for 133 warehouses, and full accountability for 3rd party services, inventories of $290M, annual issues at $130M and 258K SKUs, $7M freight budget, and corporate investment recovery of $5M
  • Led reengineering of process, production, and performance initiatives related to inbound/outbound freight, purchasing, and inventory control strategies, with reduction of SKUs by 30% through standardization, resulting in $6.1M savings
  • Designed, developed, staffed, and trained new warehouse and distribution facility to be FDA compliant, and resolved all findings based on inspection
  • Implemented SOPs for FDA compliance, staffed, and trained purchasing inventory management group, and generated six-figure annual reoccurring savings through competitive bidding and negotiations, and managed all supplier relationships
  • Performed GAP analysis comparing SOPs and practices to FDA requirements in order to develop plans to ensure compliance
  • Performed internal and supplier audits as lead auditor to ensure compliance with FDA and ISO requirements
  • Implemented lean practices, including 5S, SMED, JIT, Kanban, Kaizen, root cause analysis, process mapping, sales, and operation planning, and trained employees
  • Created, presented, and obtained approval of business plan from executive board
  • Implemented and managed strategies that increased on-time shipments to 90% and decreased back orders by 60%, which halted 5 consecutive years of $2M annual losses
  • Served as CRO and COO for multi-million dollar plastics injection and blow molding company with 60 presses, ranging from 500 tons to 2600 tons, producing household consumer goods
  • Completed situation analysis/reporting for various manufacturing and service organizations, including focused interviews, organizational review and evaluation, analytical analysis of product costs and margins, inventory analysis, customer and supplier analysis and evaluation, sales and operations planning analysis, and continuous quality improvement evaluation
  • Implemented best practices and improved productivity utilizing lean manufacturing practices, as well as benchmarking and KPIs, for plastics molding company
  • Increased machine uptime from 47% to 87% in 3 weeks as result of SMED implementation
  • Implemented 5S and SMED, as well as press-side packing, thereby reducing manpower to machine ratio from 1.87 to 1.4, which in turn generated annualized savings of $350K
  • Served as Plant Manager reorganizing and successfully turning around packaging plant that lost $3.5M each year for 3 successive years and became break-even within 1month
  • Eliminated overtime, implemented lean practices, as well as SMED and 5S, increased machine uptime from 45% to 83%, and reduced scrap from 67% to 32% through Kaizen events
  • Analyzed gross/net profits by product/SKU and developed plan to cull 13 SKUs that represented annual net loss of $1.5M
  • Transitioned spin-off medical device manufacturing company into standalone compliant and functioning entity
  • Worked with private equity firm and board as interim COO to organize, staff, conclude 2 competitors, and assimilate them into 1 viable organization
  • Negotiated and acquired IP rights for two separate and vital manufactured assemblies, saving $250K and $3M, respectively
  • Consolidated two telecommunications divisions generating over $1M in reoccurring savings, increased sales by 60% by refocusing on medical device manufacturing/remanufacturing/repairs, and achieved gross margins an average of 74%
  • Implemented a manufacturing sales forecast and an enterprise budget for medical device
  • Negotiated and signed master distributor agreements with major telecommunication clients providing diversity of products and increasing repair/refurbishment business
  • Restructured manufacturing operation and led major turnaround, growth, and profitability initiative, functioning as GM, to achieve ISO and CE Mark certification, and successfully transition strategies to first tier automotive supplier and medical device manufacturer with net change in excess of $1M
  • Introduced CQI and demand flow technology, including MUDA (waste elimination) and KANBAN, increasing production capacity 60%, reducing scrap 50%, and negotiating freight discounts exceeding $1M annually
  • Assisted $5B manufacturer by managing $19M in inventory, and creating FDA and ISO compliant procedures and work instructions to attain ISO 9001and CE Mark certifications in two Mexico plants and one U.S. distribution center
  • Implemented 90-day strategy, utilizing process mapping and Kaizen events, which decreased back orders by 70%, reduced inventories over $600K, and increased turns from 2 to 6
  • Served as COO for French based operations to consolidate two facilities, generating savings of over $2.5M, and increasing productivity by 38% and annual output by 85%

PROFESSIONAL EXPERIENCE

  • Senex Associates, Managing Partner, Principal Consultant, (Dyer, TN)
  • (Contracted with Mallinckrodt Medical, Nelcore Bennett, Hill Rom, Alcan, SanuWave, Sealtech, Duke Medical University, Kentucky Blood Centers, Dallas Bloods Centers, St. Louis Blood Centers, KCI, Jay medical, Sunrise Medical, PI Medical, Abbott Labs, Hospira, King Technologies, Inc., Synergetics, Focus Management Group, Schrudder Performance Group, Highland Group, ProGuide, and MainPointe) – 4/92 to Present
  • General Public Utilities Corporation, Dir. Materials & Logistics, (Parsippany, NJ) – 9/80 to 5/92
  • General Instruments Corporation, Operations Manager, (Frontsville, MD) – 4/76 to 6/80
  • Control Data Corporation, Materials Manager, (Rockville, MD) – 10/69 to 4/76

EDUCATION

  • Bachelor of Business Administration, Bienville University, Baton Rouge, LA, 1983

CERTIFICATION

  • Certified Professional Materials Manager (PCMM) – 1992
  • Certified Warehouse Manager (CSM) – 1995
  • Certified Lead Auditor, IRCA, (CLA) – 2001

TRAINING

  • Six Sigma, Green Belt
  • Hazardous Material Handling
  • Medical Device Manufacturing FDA Regulations
  • ISO 9001:2000
  • cGMP
  • Root Cause Analysis
  • Demand Flow College
  • Lean Manufacturing Techniques
  • Process Flow Mapping
  • MUDA (Waste Elimination)
  • Gemba (Shop Floor Focus Groups)

AFFILIATIONS

  • Board of Directors, National Industrial Warehouse Managers (NISMA)
  • American Society of Quality (ASQ)
  • International Registry of Certified Auditors (IRCA)
  • Institute for Supply Management
  • Material Handling & Management Society (MHMS)
  • American Production and Inventory Control Society (APICS)

PUBLICATIONS

  • Various publications in Transportation and Distribution (10 Technical Articles), Shipping and Receiving (4Technical Articles), Spectra (3 Technical Articles), Warehousing, Modern Material Handling, EL&P, Inbound Logistics, Material Handling Engineering, WERC, and case studies for Lehigh University (2 Technical Articles)

PRESENTATIONS

  • Various presentations at ASQ for University of North Carolina, University of Georgia, Baltimore Gas & Electric, PECO, and Material Handling Management Society, Toronto