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 Supervisors and 80+ production staff, fostering a culture of continuous improvement. Optimize production schedules, inventory, and capacity planning to meet internal and external customer demands while minimizing downtime.• 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 program. Validate Protocol initiatives for process changes and equipment design and repair. Lead select Corrective Action / Preventative Action (CAPA) initiatives to drive process improvements and compliance to required standards. Manage projects, involving cross-functional teams, to mitigate customer service issues while meeting time and budget constraints. Additional responsibilities include: Union Contract Negotiations o Management representative for 2016 & 2021 Bargaining Unit Contracts & 3rd Step Grievance process Continuous Improvement Project Leader o Lead cross functional team for SAP upgrade using Toyota Production System principals. Certified as an ISO 13485 Lead Auditor for raw material suppliers.

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 non-conformances.

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 annual report, lead OSHA investigations and develop corrective action strategies for mitigation, ensure all employees complete mandated training, certified to conduct respirator fit testing (qualitative and quantitative), certified fork-truck trainer, and lead all employees in an observation-based safety culture.

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 including training, team leadership and personnel development for Hydrogenation and Purification departments.

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 process improvements that increased throughput by 30% and revenue by $16 million annually.  Restructured packaging and warehouse units by combining job classifications and cross-training employees to perform the duties of each classification. The result is a labor savings of $800,000 annually. Designed product recycling system which eliminated all waste product in packaging department while increasing annual revenue by $2.1 million As the production representative of the safety steering committee, implemented the DuPont STOP safety program as part of the behavior based safety initiative. Successfully trained all plant supervisors and engineers in the DuPont STOP program.  Introduced total productive maintenance (TPM) activities which increased overall equipment effectiveness (OEE) by 25% while reducing maintenance costs by $600,000 Expanded international sales by 60% by working with representatives from Europe and Asia to design packaging options that met the requirements of their customers.

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. Participated in start-up team for SAP.

 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.