3D Systems, Inc. Quality Engineer in Littleton, Colorado
• The Quality Engineer is responsible for supporting the execution of quality processes in accordance with 3D Systems Quality Management System and applicable regulatory bodies.
PRIMARY JOB FUNCTIONS
• Participating on project teams as a contributing member by providing quality engineering support in the development of new products and processes, and continuously improving 3D Systems’ Healthcare products
• Contributing to the development and execution of verification & validation plans, testing, and generation of test reports
• Development and contribution to the risk management process
• Assisting project teams on compliance with design control requirements per FDA QSR, European MDD, ISO 13485 and other applicable ISO/EN standards
• Maintaining current knowledge of FDA and international regulation, guidance and standards applicable to company products
• Facilitating and performing internal QA audits as required
• Participating in the execution, maintenance and improvement of the Quality Management System.
• Analyzing reports and returned products and recommending corrective/preventive actions (CAPAs)
• Performing statistical analysis to assess cost of, and determining the responsibility for products or materials that do not meet required standards and specifications
Education and Training
• BS degree in engineering or related field is preferred
• 0-2 years of related work experience in regulated, cGMP environment such as medical device, pharmaceutical or food manufacture.
Knowledge, Skills & Abilities
• Quality assurance and reliability experience supporting product development and/or manufacturing are preferred.
• Working knowledge of GMP and ISO 13485 Quality System
• Ability to read and design engineering specifications across a number of products and materials.
• Ability to analyze and develop engineering processes for use in advanced technology implementations.
• Experience in preparing technical documentation.
Title: Quality Engineer
Requisition ID: 180000G2