Jeff Smith Email & Phone Number

Warsaw, Indiana

Quality system manager for 2 manufacturing locations. Supervise 2 quality engineers, 2 technicians, a coordinator and 4 inspectors. Responsible to keep both plants certified to ISO 13485 and compliant to Title 21 CFR 820 for the manufacture of medical instruments and implants. Conduct internal audits. Serve as the company representative for external audits. Coordinate with engineering and manufacturing on all new products, process improvements and complaint resolution.

Warsaw Indiana

Supervised the operation of robotic polishing machines, CNC mills, lathes, grinders and plunge EDMs organized in a cellular manufacturing environment. Ensured operations were compliant to FDA regulations, ISO quality standards, and followed Zimmer work instructions. Managed shift labor planning, scheduling, and employee development by cross-training associates in multiple skills and job functions with emphasis on Lean manufacturing principles.

South Whitley, Indiana

Responsibility for multi-plant operations including P&L, product management, strategic business development, and direction setting. Directed 3 plant managers in 2 countries; supervised project engineers, quality managers, schedulers, and product development engineers. Collaborated with sales teams to develop marketing plans and grow share and bottom lines.

North Webster, Indiana

Developed marketing plans for consumer products. Worked directly with customers to successfully develop and launch 2 new products from concept to commercialization. Identified potential new customers and developed financial strategies used in final decision making. Traveled extensively in target countries investigating future manufacturing sites and identifying market potential.

North Webster, Indiana

Managed company wide quality control, quality assurance activities for 4 plants. Activities included PAPP, FMEA, CAPA, metrology, SPC initiatives, document control, lot control, supplier qualification / audits and regulatory audit management / compliance.

North Webster, Indiana

Managed quality control and quality assurance activities in plant 02.

Bachelor'S Degree, Parks, Recreation And Leisure Facilities Management

Master Of Business Administration (M.B.A.), Business Administration And Management, General

Certificate - Lean Manufacturing Tps