Rick Witzke CPIM
Wake forest, NC 27587
317-***-**** **********@*****.***
SUMMARY
I am action oriented executive with broad-based Manufacturing experience in development, planning, executing and control of FDA complaint manufacturing operations and supply chains.. Effectively created and directed teams across the entire supply chain in an environment of operational excellence. Proven track record of excellence in management of Medical Device manufacturing following cGMP and ISO13485 practices. I am an experienced leader with expertise in:
Strategic Manufacturing Planning, CPIM Certified,
Demand based forecasting
Empowerment and Team Management
Commitment to Servant Leadership
Warehouse Management.
IVD Device /Reagent manufacturing
Cap/CLIA Laboratory Supply Chain
ERP Expert in Implementation and Execution of, Oracle, Fourth Shift, and Epicor Vantage ERP systems.
Facility Management and Planning
Capacity Analysis/Expansion
International and domestic Logistics Management/Reverse Logistics
ISO 13485 Implementation and Compliance execution
FDA GMP Compliance
Lean Manufacturing, Six Sigma Green belt.
PROFESIONAL EXPERIENCE
Lab Corp of America/ LipoScience Inc.
IVD Manufacture CAP/CLIA Laboratory 2012-Current
Supply Chain Manager
Responsible for creating a FDA compliant Supply Chain and overseeing the outsourced Manufacturing for the Vantera IVD Device and reagents.
Responsibilities
Developed entire supply chain from forecast development to customer product delivery that insured customer satisfaction and investor returns.
Managed and oversight contract manufacturing of IVD device.
Outsourced and over sought contract manufacturing of reagent manufacturing for use in the IVD device.
Responsible for all procurement and negotiated supplier contracts to support lowest total procurement cost to the company. Resulted in 18% reduction in logistics cost and 10% reduction in Laboratory cost in first year
Functional development of Oracle R12.1.3 system. Created a system of control from purchasing to customer order and shipment process while maintaining inventory levels and accuracy of over 99%
Developed Logistics to execute the delivery of supplies and return of patient samples for over 6,000 customers.
Managed facility operations, contracts and maintenance to ensure compliance to ISO, FDA and CAP CLIA Guideline.
Develop process flows and lean process within the Laboratory operations resulting in a 15% reduction in labor requirements.
Helmer Scientific, Noblesville, IN 1987-2012
A leader in the Medical Device industry.
Director of Manufacturing and Supply Chain
Responsible for the Manufacturing Operations, Supply Chain Execution, and Facilities Management for the worldwide supplier of laboratory and refrigerated life science equipment.
Responsibilities:
Served as senior management to set company culture of continual improvement through lean principals and “Growth with Honor”. Developed Human resource values.
Developed and executed business strategic plan to serve customers, employees and shareholders. .
Developed and lead entire FDA/ISO 13485 150,000 SQ foot Medical device manufacture operations using Lean, TQM, and Six Sigma Principles.
Developed cGMP Complaint supply chain serving over 52 different countries.
Complete oversight of logistics for both domestic and international shipping importing and exporting of components and finished products.
Established supply chain objectives and implemented KPI’s to Communicate supply chain performance.
Lead industrial engineering in the design transfer from product development to manufacturing. Developed work instructions using procedures and processes that were FDA, GMP, and ISO13485 compliant.
Established supply chain objectives and implemented KPI’s to track performance.
Directed procurement team for over 20 million in annual spending.
Developed Facilities capacity planning, maintenance procedures and controls.
Implemented a safety program, tracked results and implemented corrective actions.
Managed the logistics operations including importing and exporting.
Major accomplishments:
Built a culture of employee growth and empowerment.
Led the company through growth from less than a million in sales to over 50 million and from 10 employees to over 200.
Established supply chain that maintained inventory levels at less than six percent of sales and inventory turns of 12 per year on over 7,000 skew numbers.
Led logistics program from a losing operation to a profit center.
Directed the Planning and Construction of 2 completely new facilities. 87,000 and 150,000 Square feet.
Developed a state of the art automated sheet metal processing and powder coating facility.
Launched an assembly to order Manufacturing environment allowing the customization to over 80 percent of units and with order fulfillment in less than industry standard product lead time.
Led Company team with implementation of two ERP systems (Fourth Shift & Epicor Vantage).
Served as part of non-profit community developments around the world. Assisted business development training in Rwanda, Africa and Chichicastenago, Guatemala.
Manufacturing Manager (Helmer Inc) 1987-1996
Led the Manufacturing operations and Technical Service teams.
Responsibilities:
Set daily production schedule.
Managed hiring of all production employees.
Established and led the CNC programing department.
Transferred new products though prototype and production phases.
Maintain inventory and purchasing Controls.
Developed growth plan to support short term capacity constraints.
US Marine Corp 1982-1986
Platoon Leader E-4
NCO Leadership School
EDUCATION AND PROFESSIONAL DEVELOPMENT
American Production and Inventory Society CPIM Certified
Six Sigma Green Belt Certification.
University Of Wisconsin Industrial Engineering Certificate
Wilson Tool Lean for the Sheet Metal Facility Certificate
IUPUI Detailed Project Planning and Managing Multiply Projects
Mitsubishi Level 2 Laser Certified
OSHA 30HR Certified
University of Purdue Level 2 Advanced Manufacturing Practitioner Certificate
Emergo ISO 14971 Risk Assessment Training
Refrigeration Service Engineers Society Certificate
PROFESSIONAL AFFILIATIONS
A.P.I.C.S. (American Production and Inventory Control Society)
Purdue University T.A.P Program