Key member of dedicated product improvement teams. Lead in the development, maintenance and reporting on Quality system processes who plans, coordinates, and directs the quality assurance program. Ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates. This position is a Quality Engineer position, in a Manufacturing environment in our Georgia facility.
Essential duties and responsibilities include the following:
Ensures compliance with Class II Medical Devices including but not limited to, the Medical Device Directive, ADR/Transportable Pressure Equipment Directive (TPED), FDA/21 CFR 820, and certification of DOT-4L.
Supports and ensures successful completion of third party audits for Operations.
Performs and coordinates internal audits/training to ensure continuing compliance with quality system standards (ISO 9001, 13485, 188001 and 14001) and the manufacture of safe products.
Perform statistical analysis of production process, including Supplier components and report findings. Previous experience with manufacturing or product quality related data analytics such as process capabilities, SPC, Pareto, or other related data. Working knowledge of Six Sigma techniques, Green Belt or better a plus.
Drives continual improvement through use of quality tools and development of manufacturing and support personnel.
Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, processes and products.
Maintains a timely, effective corrective/preventive action process.
Works to control and manage quality costs and assure appropriate distribution of resources.
Performs other duties as assigned by Quality Assurance Manager.
May directly supervise areas of the Quality Assurance Department. Performs any supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing, hiring and training employees; planning; assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Domestic and International travel opportunities- possibly
PHYSICAL DEMANDS:While performing the duties of this job, the employee is regularly required to stand, walk, sit, and taste or smell. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.
Four year college degree and / or equivalent plus one to three years related experience in ISO 9000 Quality Systems and/or ASME, European Directives; or equivalent combination of education and experience. Working knowledge of MS Office required.
Chart Industries is an equal employment opportunity employer
Four year college degree and / or equivalent plus one to three years related experience in ISO 9000 Quality Systems and/or ASME, European Directives; or equivalent combination of education and experience. Working knowledge of MS Office required
About Chart Industries
Chart Industries, Inc. is a leading global supplier of standard and custom engineered products and systems serving a wide variety of low-temperature and cryogenic applications. Chart manufactures a broad line of cryogenic products for the purification, liquefaction, distribution, storage and application of gases such as helium, nitrogen, argon, oxygen, carbon dioxide, natural gas and other hydrocarbons for final use in a multitude of industrial, commercial and scientific applications. These applications serve many selected markets including biomedical, food, entertainment, aerospace, thermal testing, alternative fuels, vacuum systems and many other industrial end users.