Share Email Opening Apply Now Title Quality Engineer  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description The quality engineer position works directly with engineering and Customer Service personnel, analyzing incoming inspection processes for improvement using various methods of testing and inspection. Interacts with incoming and in process inspectors as necessary to troubleshoot and solve quality related issues. Responsibilties: Ability to fulfill VitalMED Quality Statement goals. Understand and follow the Health and Safety policy of VitalMED. Responsible for incoming inspection support by suggesting and implementing improvements and troubleshooting issues. Developing and improving new and current fixtures used in inspection. Serve as back up inspector for inspection of all incoming goods by following inspection procedures and criteria specific to quality assurance standards. Completion of all necessary company and quality documentation. Process of Engineering Change Orders and update file documentation according to procedures. Ensures that all other duties as assigned are completed as requested in a timely manner. Promote and execute quality standards, inspection processes, test methodology, quality plans, documents and reports. Develop, execute and analyze quality-reporting measures. Report to management on quality issues, trends and losses. Review suppliers purchase orders and establish supplier quality requirements. Participate in internal and external quality audits. Interface with supplier and customer quality representatives concerning problems with quality assurance and assure that effective corrective action is implemented. May compile, write and deliver training material on quality standards and activities. Serve as ISO Management Representative as required. Complete other duties as assigned. Qualifications: Prefer a BS in Engineering or equivalent training and experience. Experience in the Quality Assurance field, Medical Device industry is preferred. Knowledge of ISO 9001, ISO13485 and GMP standards. Company SOPs: See Training Matrix Technical Drawings (GD&T) and Metrology techniques. AutoCad, SolidWorks knowledge preferred   Position Requirements   Location VitlaMed   About the Organization Based in Alpharetta, Georgia with multiple plants across the United States, Mexico, Costa Rica, Ireland and Malaysia, Spectrum Plastics Group is a North American leader in the development and manufacture of specialty medical plastic products. Only Spectrum Plastics Group has the product breadth, expertise and global reach to deliver critical medical plastics at scale. We deliver operational excellence, innovative solutions and a high level of execution resulting in what our customers value most: precision, performance and repeatability. Spectrum Plastics Group offers a full range of custom design, engineering and fabrication services, as well as meets the requirements of ISO 9001, ISO 13485, FDA, operating multiple Class 7 & Class 8 clean rooms. When medical plastics are critical, the industry trusts us. Specialties: High performance extrusion Tight tolerance extrusion Extrusion Precision injection-molding Micro-molding Medical tubing PVC tubing Silicone Packaging Finished Devices/Assembly Contract manufacturing Clean room Thermoplastic tubing extrusion Medical device Medical plastics Medical components Microbore extrusion Bioabsorbables Catheters   This position is currently accepting applications. Apply Now Follow us See who works here:

 

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