MARK D. VILLANOVA MT (ASCP)

W***N**** Loghouse Circle Oconomowoc, WI, 53066 262-***-**** ac31qh@r.postjobfree.com OBJECTIVE

To obtain a position that will provide the opportunity to maximize my 25+ years of experience in management, quality assurance, program and product development, supply chain, and training with the goal of raising the overall efficiency of an organization while maintaining the adherence to applicable regulations and best business practices.

SYSMEX AMERICA, INC. Lincolnshire, Illinois 2006 – 2017 Sysmex Corporation manufactures clinical testing devices, and is engaged in R&D, production, marketing, servicing and support of instruments, reagents, and software for hematology, urinalysis, and immunochemistry. Sysmex employs over 7,400 and generates over $2.1 billion in global sales annually. Director of Strategic Initiatives 2015 – 2017

Responsible for coordinating innovative projects to minimize service costs and increase customer satisfaction during a period of significant company growth.

• Led a cross-functional team to resolve a third party vendor issue that resulted in an FDA compliant resolution that prevented the necessity of an MDR and identified the vendor to be financially responsible and the need to enhance the validation and verification process for component changes which impact the product design. This rapid response avoided a potential cost of over $155,000 and a direct impact on customer satisfaction.

• Maintained a key role on the CAPA Corporate Review Board which collected and analyzed information to identify actual and potential product and quality problems, take appropriate corrective and preventive action and to verify or validate the effectiveness of the corrective actions on a corporate-wide level.

• Acted as the Technical Services responsible individual working with FDA pre-audits and audits, providing the necessary information requested and addressing any observations and citations. Utilized the International Organization for Standardization (ISO) 13485 standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

• Integrated Healthcare Technology Management (BMET) business into customer service agreement options, opening new sales opportunities resulting in over $5 million annually.

• Expanded application of the Sysmex Evidence-Based Maintenance program, based on throughput, analyzer messages, and service history, reducing service costs by 17%.

• Introduced a local service option for a hematology analyzer previously serviced only by a return and repair model which also opened new sales opportunities.

• Planned comprehensive service support for the release of three new products which led to the successful launch of each.

• Decreased service costs by 20% and increased customer satisfaction by improving evidence- based calibration process to allow remote calibration of analyzers.

• Selected and coordinated a third party partner to service upcoming point of care product launch with sales projected at 9,000 analyzers over a three-year period, allowing the focus on the higher-end customer base and speeding the launch plans by 12 months. Director of Service Operations 2013 – 2015

Responsible for optimizing a $9 million service inventory and for streamlining the processing for the depot repair of a point of care analyzer and the process for the preassembly and verification of large hematology automation analyzers prior to shipment to customer locations.

• Led the Technical Services Team in the review, disposition, and rework plans, if applicable for all service nonconforming products.

• Led the formulation of region specific product change requests for the nonconforming products, when the design control requirements from CFR820.30, were not met.

• Member in a team of 6 leaders on the CAPA Corporate Review Board which collected and analyzed information to identify actual and potential product and quality problems, take appropriate corrective and preventive action and to verify or validate the effectiveness of the corrective actions on a corporate-wide level.

• Instituted the first process for product rework, following CFR820.90. This lead to the annual savings of over $250K and decreased lead time by 85%.

• Generated a $2 million reduction ($9 million to $7 million) in one year while preventing stockout situations through planning and optimizing service part inventory.

• Secured inventory specialists and training for PTC Service Lifecycle Management (SLM). Which led to a 40 day decrease in lead time.

• Improved lead time and optimized parts availability for new, current, and discontinued instrumentation by implementing global best practices.

• Co-led international program execution that then became adopted across all Sysmex regions. Director of Technical Education and Inventory 2010 – 2013 Responsible for the improvement of the Technical Education and Development Center that required a decrease in the time required for a new hire to become an effective service representative. Also responsible for the further refinement of the service supply chain process.

• Developed the training matrix of the necessary procedures that need to be initially and annually trained to for specific associate job levels.

• Participated on the CAPA Review Board to review and develop the necessary direction to close CAPA issues in a timely manner, linking the CAPA to risk management as prescribed in ISO 14971.

• Generated savings of $5 million over a 3-year period, increased part turnover, and streamlined supply chain process by expanding the shipment window through coordination of a major warehousing transition for service part inventory

• Delivered presentations on evidence-based maintenance and inventory planning and optimization at the Global Management Meeting which relayed the information that led to an expanded budget in these areas.

• Decreased time required to advance a new hire from training to field work 25% by improving Technical Education and Development Center through facility and training curriculum updates.

• Designed a service engineer trainee program for new hires in anticipation of customer acquisitions, preventing a possible six-month delay in adequate service support which opened more sales opportunities.

MARK D. VILLANOVA PAGE 2

Technical Product Manager 2006 – 2010

Responsible for managing the cost of service for multiple analyzers and several new product launches.

• Researched and applied the initial use of Six Sigma Lean Process towards the goal of decreasing service costs and risks at Sysmex. This lead to an overall decrease in the service costs of over 15%.

• Assisted in the requirements for new product development ensuring that 21 CFR 820.30 requirements where followed.

• Decreased impacted customer downtime 40% by developing escalation procedure to manage increased repair time incidents

• Established a global partnership with CellaVision AB, a cellular imaging company, which led to a global partnership.

• Managed multiple analyzers from the development stage to initial training plan execution, securing an average decrease in the cost of service of 16% for those products. BECKMAN COULTER, INC. Brea, California 1991 – 2006 Beckman Coulter develops, manufactures, and markets products that simplify, automate, and innovate complex biomedical and industrial testing. 10,000 employees, $2.4 billion in annual sales, and operations in over 130 countries in diagnostics, industrial, and research and discovery business. Area Technical Manager 2003-2006 Responsible for the installation, customer training, and advanced servicing of escalated issues for the products in the hematology, hemostasis, immunology, and clinical chemistry areas.

• Led 28 medical technologists and technical consultants to provide implementation training and advanced technical support for laboratory instrumentation in hematology, hemostasis, chemistry, and immunology across a 10-state North Central area resulting in an increase of customer satisfaction at installation of 20% and post installation of 10%. District Service Manager 2000-2003

Responsible for the management of a staff of 19 field service engineers providing installation support and rapid resolutions to service issues on the full range of BCI instrumentation in the Chicagoland area.

• Coordinated the plan to perform over 600 overdue preventative maintenance visits while improving customer satisfaction levels 15% without increasing overtime hours in a 6-month period.

Area Hardware Specialist 1996-2000

Responsible for the advanced direct field support for hematology and hemostasis service engineers. Field Service Engineer 1991-1996

Responsible for the technical service for hematology and hemostasis laboratory instrumentation across a 3- state area, while adhering to 21 CFR820.

Saint Thomas Medical Center Akron, Ohio 1978-1991

Medical Technologist 1989-1991

Responsible for the second and third shift clinical laboratory supervision. This included the scheduling and work quality verification for all departments of a major medical center clinical laboratory. Assisted in the adherence to the Clinical Laboratory Improvement Amendments (CLIA) regarding the complexity of assays performed and planned.

MARK D. VILLANOVA PAGE 3

EDUCATION, TRAINING and APPLICATIONS

BS Biology-Medical Technology Kent State University Lasater Institute Six Sigma Training

Loyola University Leadership Training

AMA Training the Trainer certification

Microsoft Excel, Visio, PowerPoint, SharePoint, Word, OneNote, Publisher, Outlook, TrackWise, Metrix CRM, SAP, Inventory Optimization, Tableau, Multiple Learning Management Systems(LMS) MARK D. VILLANOVA PAGE 4

Contact this candidate