Quality Engineer- Medical Manufacturing
Ball Ground, GA | Direct Hire
Our customer in the North West Georgia area is currently looking for a Quality Engineer to join their team on a long term, direct hire basis.
• Plans, coordinates, and directs the quality assurance program designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates:
• 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.
• Coordinates and ensures successful completion of third party audits.
• Performs and coordinates internal audits/training to ensure continuing compliance with quality system standards (ISO 9001 & 14001) and the manufacture of safe products.
• Perform statistical analysis of production process, including Supplier components and report findings.
• 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.
• Assemble and certify documentation/vessels for Code and customer compliance.
• Drives continual improvement through use of quality tools and development of manufacturing and support personnel.
• Works to control and manage quality costs and assure appropriate distribution of resources.
• Performs other duties as assigned by Quality Assurance Manager.
• Four year college degree and / or equivalent
• 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.
• ASQ CQE, CQA, and/or CMQ/OE preferred.
• Demonstrated quality program implementation experience required
Please send updated resumes to tyler.Daniel@trcstaffing.Com