Operations Manager
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.
RESPONSIBILITIES:
•    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.
QUALIFICATIONS:
•    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