The 3D Systems site in Littleton, Colorado needs a skilled Quality Engineer to augment the Development Quality team under the direction of the Quality Engineering Supervisor. The mission of the Development Quality team is to ensure 3D Systems' products and/or services for new customers provide a high level of quality that meets expectations. Our pace of growth is only matched by the pace at which our customers expect their new and innovative products to be delivered. This position will support the Product Development and Solutions team to develop new 3D Systems' and contract manufacturing products through a product development process.
Organization:
As part of the Healthcare unit of 3D Systems, the Littleton facility acts as a service bureau to enable customers without the expertise, capital, or desire to additively manufacture their products. We are experts in digital workflows, patient-specific devices, and five different kinds of 3D printing. The Quality department serves both the Virtual Surgical Planning as well as the Contract Manufacturing product lines with plastic and metal additive manufacturing.
Performance Objectives:
The following performance objectives will determine job success for this position:
Develop Product Quality Processes : Utilize existing processes and inspection methods and augment capabilities with new processes to meet technical requirements of internally and externally driven projects. Specify, justify financially, develop, and implement new methods for ensuring the quality of product produced at 3D Systems.
Conduct Process and Product Validation : Participate in cross functional team to develop and execute test protocols for the verification and validation of new products, materials, equipment, software, and processes. Perform statistical analysis of data to assess viability of product designs and manufacturing processes.
Perform Measurement System Analysis : Identify and evaluate measurement systems to ensure accuracy, precision and stability used to assess product conformity.
Resolve technical issues: Follow developed processes and projects through design transfer and in to the first year of volume production. Working within a cross-functional team, ensure that insufficiently developed processes are remediated, work instructions are updated, and scrap is minimized. Document the results of investigation and resolution through the CAPA, NMR, or Deviation processes.
Qualify New Suppliers : Evaluate new candidate suppliers to ensure they meet the operational and quality needs of 3D Systems as governed by applicable regulatory bodies such as the FDA.
Facilitate Design Control Process : Following internal procedures for product and process development, participate in the transfer of new projects into Manufacturing. Ensure that all required quality documentation is complete and released.
Navigate Product and Process Requirements : Participate in project meetings and lead efforts to translate and understand part, project, and validation requirements. Participate in complaint investigations, gather product conformity information, and coordinate with internal and external stakeholders to optimize product quality.
Create Device Master Records : Author work instructions in visual format for the inspection and release of product. Implement all changes via the formal document control system.
Perform Batch Release : Review device history records, ensure compliance to predetermined specifications, and generate product release documentation, including certificates of analysis and conformity.
This document represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described.
Education and Training
BS degree in engineering or related field
Experience
1-3 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 cGMP and ISO 13485 Quality System
Ability to read and understand 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.
A successful candidate for this position will be a U.S. Person.
