3D Systems Littleton specializes in 3D printed personalized healthcare solutions and advanced manufacturing capabilities. The Quality Engineer is responsible assuring product conformity to exceed customer expectations by supporting the execution of quality processes in accordance with 3D Systems Quality Management System, applicable regulatory bodies, and customer requirements.
Manage Quality functions (inspection, test activities, nonconformities) for finished device and contract manufactured products.
Develop specifications, work instructions, test plans, and all other customer required quality documentation.
Analyze quality metrics, review trends, and manage/participate in CAPAs.
Review feedback, investigate complaints, and effectively communicate results to customers.
Identify potential risks and perform risk management activities
Work on continual improvement activities to optimize quality system.
Develop training to build quality awareness
Provide support for internal and external audit activities.
Perform IQ, OQ, PQ and validations to support new and existing production lines.
Education and Training
B.S. in Engineering or related technical field preferred.
Combination of education and experience may be considered
0-2 years related experience in regulated environment
Knowledge of ISO 13485, ISO 9001, and AS9100 a plus