CAREER SUMMARY

Experienced manager and scientist with extensive background in operations management, manufacturing processes, reagent engineering and medical research. Skilled team player, strategist, and implementer in directing cross-functional activities and projects.

EXPERIENCE

2001 to Present
CHS Business Associates, Avon, OH
Founder and President - Focused on assisting medical device manufacturers and other companies to meet and exceed goals through assessment, gap analysis and remediation activities in the areas of Quality systems, supplier management, FDA, ISO regulatory compliance, manufacturing and R&D.

Consulting for large medical device manufacturer.

• Lead a cross functional supplier quality team to establish Supplier Quality Management practices and globally implement across all business segments
  • Identify both internal and external best practices and incorporate advanced processes into the Global Supplier Quality System
  • Develop supporting documentation to ensure suppliers are fully engaged in the quality vision and supporting joint goals
• Integrate the processes which are developed by the team into the Global Quality System Strategic Plan
• Supplier attributed field corrective actions dropped > 60% during supplier quality management effort resulting in a cost avoidance of an estimated $1,400,000
• Validation Improvement Project implemented across 4 business segments. Focus on validation improvements in R&D development design, Process, and software business processes. Identified opportunity for > $600,000/yr savings
• Global implementation of Document Management System. Rolled out to over 4000 users in 6 weeks. Annualized savings of > $160,000
• Generate guidance document for the development of contracts with outsourcing of Product Design activities, Other Equipment Manufacturer (OEM) management processes and Contract Manufacturing.

2000-2001
Marconi Power Systems, Lorain, OH
Major manufacturer of telecommunications power conversion systems.

Manager Engineered Assemblies, 2001
Managed purchase of all outsourced assemblies.

Responsible for $75M in inventory.
Operations Project Manager, 2000 to 2001
Supervised the development and implementation of strategy for outsourcing.

• Developed and implemented process for supplier selection and performance measurement.
• Directed cross-functional team in the development of outsourcing of printed circuit boards, wire forms and small transformers.
• Generated $3M of inventory reduction.
• Served on committee to re-deploy manufacturing associates.
• Achieved $2.5M cost reduction by developing new ship and distribution strategies for materials management.

1990-2000
Bayer Diagnostics, Oberlin, OH
Major manufacturer of medical instrumentation used in hospital laboratories.

Manufacturing Manager 1993 to 2000
Directed 120 people in the manufacture of four clinical analyzers. Served as Continuous Improvement Coordinator.

• Achieved 30% reduction in product manufacturing cycle time by identifying and eliminating unnecessary activities.
• Generated 20% improvement in first pass yield of product quality testing.
• Served on ISO 9001 implementation and FDA/GMP compliance teams.
• Served on Plant Safety Advisory Committee.
• Developed and implemented strategy to outsource reagent manufacturing.
• Attained a 4% reduction in standard costs in the first year.
• Improved on-time delivery 20% within the first 3 months.

Reagent Engineering Manager 1991 to 1993
Directed Clinical Chemistry business unit.

• Developed and administered $300,000 R&D budget.
• Achieved 25% reduction in product development cycle.
• Ensured compliance with ISO 9001, FDA, OSHA, and company safety and health regulations.

Clinical Chemistry R&D Scientist 1990 to 1991
Researched immunoassays and managed reagent formulation group.

• Developed three immunoassays for use on the EXPRESS chemistry analyzer.
• Designed and performed operations support protocols.
• Trained laboratory technicians.
• Served as department safety officer.

1968-1990
MetroHealth Medical Center, Cleveland, OH
Regional Health Center and teaching hospital, Case Western Reserve University

Research Scientist
Designed implemented and evaluated research protocols.

• Wrote research grants for local and national funding agencies.
• Isolated, characterized, and purified proteins from different animal species.
• Developed screening test for B2 microglobulin used to screen people for Balkan Nephropathy.
• Conducted studies on renal protein metabolism and detection of renal injury.

SKILLS

Microsoft Office, SAP, BPCS, Microsoft Project

PROFESSIONAL ASSOCIATIONS

American Association for Manufacturing Excellence
American Management Association

COMMUNITY SERVICE

Baycrafters Association for the Visual Arts - President

EDUCATION

MBA, Executive Program, Baldwin Wallace College, Berea, Ohio
B.A. in Chemistry, Case Western Reserve University, Cleveland, Ohio

ADDITIONAL TRAINING

Establishing International Joint Ventures and Strategic Alliances
Facilitator Training
Zenger-Miller "Working Program" Facilitator Training
Teambuilding Seminars