Ensuring Chart's Success
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.
What Your Day to Day Activities Will Be..
- 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.
SUPERVISORY RESPONSIBILITIES: May directly supervise areas of the Quality Assurance Department. Performs any supervisory responsibilities in accordance with the organizationolicies 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.
Your Professional Experience Should Beclass="new_p"> One to three years related experience in ISO 9000 Quality Systems and/or ASME, European Directives;
Familiar with codes such as ISO13485 or FDA
Working knowledge of MS Office required.
Knowledge of Medical Devices a plus.
Your Education Should Be...
Four year college degree and / or equivalent or equivalent combination of education and experience.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Chart Industries is an equal employment opportunity employer.