Rob Needham Email & Phone Number

Kirksville, Missouri, United States

• Lead daily manufacturing operations for Class I and II medical devices, overseeing injection molding production in compliance with safety, environmental, quality, and regulatory standards. Manage a team of 5.
• Spearheaded process optimization initiatives, saving over $600K annually in labor efficiency.
• Reduced component scrap by 35% through TPS-based continuous improvement strategies.
• Successfully negotiated key language in labor contracts, consolidating departments and reducing headcount.

Kirksville, Missouri, United States

Responsible for managing / developing a team consisting of 3 Quality Engineers, a Quality Supervisor, and 12 Quality Inspectors to ensure compliance to FDA / ISO 13485 standards for medical device manufacturing facility. Manage Incoming, In-process and Finished Good inspection requirements including oversite of Calibration program and internal audit.

Kirksville, Missouri, United States

Coordinated a team of 12 Quality Inspectors including management of day to day inspections in Incoming, In-Process, and Sterile process laboratories. Monitored sterilization results and approved batch release for sterile products. Investigated customer complaints, as well as internal quality issues, collaborating with quality engineers to resolve.

Keokuk, Iowa, United States

Responsible for development and implementation of plant-wide safety programs with accountability to latest OSHA standards and NIOSH, NFPA guidelines. Established and facilitated company safety steering team with integration of bargaining unit leadership and departmental safety committees. Other responsibilities include: maintain OSHA 300 log and submit.

Keokuk, Iowa, United States

Manager with responsibility for strategic planning, operational management and budget management of Liquid Polyols refinery including development and regulatory compliance of PSM (Process Safety Management) program in the Hydrogenation process. Lead a cross-functional team of 4 Shift Supervisors, 2 Project Coordinators, and 16 bargaining unit employees.

Keokuk, Iowa, United States

 Departmental manager of Dextrose Refinery (Pharmaceutical) with supervisory responsibilities for 10 bargaining unit employees and one Project Coordinator. Operated all aspects of the process and managed the refinery through a company / union lockout, successfully training a temporary workforce to meet the production requirements of our customers.

Indianapolis, Indiana, United States

Managed modified starch treating/drying and packaging departments including safety, quality assurance, procurement, maintenance and regulatory compliance. Monitor a team of 5 supervisors and over 80 staff members including training, team leadership and personnel development. Select accomplishments include: Utilized six sigma techniques to introduce.

Indianapolis, Indiana Area

 Developed a Hazard Analysis of Critical Control Points (HACCP) program for facility. Resulted in acquiring major market account creating additional revenue of $85M. Designed new bulk unloading system for treating department reducing costs by $80,000 annually while increasing capacity to supply an additional 10,000 lbs of finished product per day.

Indianapolis, Indiana, United States

 Implemented new scheduling techniques which increased quality of product in packaging department by 50%, increased production by 10% (company record for 2000) and lowered costs by 5%. Reduced labor costs by $160,000 while increasing production by 5%. Implemented behavior based safety programs. Trained employees to conduct Job Safety Analysis..

 Supervised 40 union employees in 5 departments on a rotational shift basis

Indianapolis, Indiana, United States

 Utilized wet chemistry analysis for testing in-process and final product starch samples.