Michael Moniz Email & Phone Number

Waltham, Ma, Us

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Danvers, Ma, Us

Beverly, Ma, Us

Served as head of Quality and Regulatory in order to implement global strategies to improve quality systems, continuous improvements, change controls and data driven performance metrics. Served as Head of R&D in order to improve development processes emphasizing interdisciplinary team, lean development principles • Lead the ISO 9001/13485 based quality programs globally (products registered in over 65 countries) • Worked with FDA and Notified Bodies for regulatory approval of class II products Clip Applier Sterilization Tray ReNew Sterilization Tray ReNew Reusable Laparoscopic surgical system Advanced Energy Laparoscopic devices • Lead on clinical marketing studies for class II devices. • Lead teams in all post-market surveillance activities including risk assessments and field actions. • Expert in product development, manufacturing and supply chain. • Development Projects Included: Advanced Energy device for use in a robotic trocar system Advanced Energy vessel sealing laparoscopic device Advanced Energy device for use in a laparoscopic robot system Re-usable advanced energy ENT forceps Next generation Laparoscopic devices Endo-mechanical end effectors for robotic surgery system 3mm endoscopic clip applier • Implemented programs to enhance quality culture through data driven metrics (Quality First program) • Developed and executed regulatory strategies for all device registration activities world wide with emphasis on FDA,510K, EU CE mark, Japan JPAL and Canada CAMDCAS • Designed and implemented regulatory policies for change assessments, post market activities and development processes • Developed new handheld laparoscopic surgical devices. • Developed laparoscopic, surgical robotic advanced energy devices.

Marlborough, Ma, Us

Served as part of a quality, leadership team hired in response to FDA warning letters. Re-engineered and re-established quality systems involved in product control processes at Boston Scientific. Served as site Head of Quality/Management Rep for Manufacturing, Distribution and Sterilization sites.• Subject Matter Expert on ISO and FDA audits.• Certified Designated Representative States of Florida and California.• Extensive knowledge of FDA QSR and cGMP regulations, ISO13485 and ISO9001• Implemented improved production processes including in-process inspection, label accountability, statistical process control for kitting and made-to-order operations.• Corporate Subject Matter expert for Quality Control and Non-conforming material • Lead lean six sigma efforts to increase inbound processing 24%.• Lead several Corporate Corrective and Preventative Action Teams• SME for several Corporate Warning Letter remediation teams: Ship Holds, Product Release, Incoming Inspection• Extensive knowledge of SAP including the Quality Module (QM), Sales and Distribution Module (SD) as well as Material management and Production Planning Modules (MM/PP)• Familiarity with Corporate validation processes and qualification processes• Familiarity with Product Design Processes(PDP)

Established and developed all Operations systems: including quality system, documentation system, design histories, design controls, contract manufacturing, complaints, customer service and CRM. • Served as Management Representative• Passed two FDA audits with no non-conformances, observations or recommendations• Shipped out first product within the first eight weeks of operation.• Achieved ISO 9001:2000, ISO13485:2001, CE and Canadian certifications within first year of operations• Established GMP/ISO compliant manufacturing processes, purchasing processes, inventory controls and warehousing processes• Three 510K approvals within first 18 months• Achieved profitability in third quarter of operations.• Launched two new disposable kits in first year.

Manage supply chain from negotiation with contract vendors to installation to customer training, ensuring overall quality. Perform strategic planning and manage daily operations with complete responsibility for $1.2M annual budget. Ensure quality and efficiency of processes and systems through effective direction of design, testing, and validation of all processes including SAP, service, CRM, and E-mail applications. Oversee development and implementation of e-commerce objectives/ programs ranging from on-line ordering/tracking to integration of SAP and Internet. Manage all aspects of customer service, upgrading and improving complaint handling systems, and overseeing ACD. Maintain rapport with European manufacturing partner, coordinating all aspects of expansion. Design, implement, and manage multiple internal/external training programs.• Responsible for Operations in Registered New Hampshire Pharmacy distributing UroMed Product• Responsible for 24% revenue growth in one year. • Successfully motivate and direct dedicated quality team in pursuit of continuous revenue and quality improvement. • Implemented vendor rating and improvement programs resulting in quality improvement, production cycle reduction, and automation of delivery schedules.• Reduced internal inspection staff costs by 50% as a result of decreasing the number of contract manufacturers by 30%.• Provided for increased revenues and streamlined operations through successful integration of forecasting/planning and web site development with sales and marketing efforts. Reduced DCO processing time by 75% through successful implementation of electronic document management conversion. • Saved $200,000 in scrap seed costs through development of inventory tracking system providing for increased accuracy and efficiency. • Directed internal staff in migration from SAP 30D to 40B. • Responsible for smallest worldwide implementation of SAP R/3 using only internal staff.

Selected, implemented, and managed all medical center technology, ensuring compliance with all industry standards. Determined and implement upgrades including those for network migration firms, cabling systems, hubs, concentrators, and routers. Developed Database programs improving productivity and providing for quality assurance. Performed all network troubleshooting. Provided comprehensive hardware and software training including development of physician training guides, quarterly newsletters, and windows based training programs. Developed and maintained excellent communications and relationships with all internal staff ranging from shift workers to Chief Surgeons.

M.S., Biomedical Engineering

B.S., Aerospace Engineering

B.A., Chemistry