We are currently partnering with a growing Medical Device company located in Kennesaw, GA who is looking to add an experienced Operations Manager to their growing team. This would be a direct hire position that includes a competitive salary and benefits. The company is looking to hire immediately.
• Oversee production and manufacturing line, IT services, and logistics functions. Ensure smooth operation of facility, equipment and planning while meeting objectives.
• Develop, evaluate and implement process improvements to increase output and increase yields.
• Perform corrective and preventive actions (CAPA) in support of Quality.
• Facilitate the development of external subject matter expertise for process development, process characterization, validation, and manufacturing.
• Identifies and implements new practices and processes that are “best in class.”
• Use key performance measures to find a better way of doing things through
• Kaizen and other tools.
• Strong mechanical aptitude, previous experience designing and executing DOEs and equipment qualifications.
• Motivate, oversee personnel, scheduling, professional development and hiring.
• Act as lead technical person for laser fibers and possible other minimally invasive device manufacturing processes, equipment, and capabilities.
• Oversee logistics operations including purchasing, shipping, receiving, are
• Collaborate with other Managers and with other departments to maintain alignment of corporate objectives.
• Drive continuous improvement through trend reporting analysis and metrics management.
• Develop and execute on a strategy for manufacturing capabilities to meet the current and future needs of the organization.
• BS in Engineering (or related technical field) and 7+ years manufacturing and process engineering experience with disposable medical devices.
• Planning, quality and supply chain knowledge in a regulated environment is a plus 2 years’ supervisory experience.
• SPC and/or Minitab Statistical analysis software a plus
• ISO 9000:2001, FDA ,GMP Knowledge
• Six Sigma/Lean Manufacturing methodology Green/Black Belt