3D Systems, Inc. Quality Engineer in Littleton, Colorado

JOB SUMMARY:

• 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

Experience

• 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

Location: CO-Littleton

Requisition ID: 180000G2