Quality Engineer Ii

Quality Engineer II

What We Are Looking For:
The 3D Systems site in Littleton, Colorado needs a skilled Quality Engineer to support production and post-production activities under the direction of the Production Quality Manager. The mission of the Quality team is to ensure 3D System's products or services for provide a high level of quality that meets expectations.

Who We Are:
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:

       Support Quality Management System: Participate in the execution, maintenance and improvement of the Quality Management System in accordance with the requirements of USFDA CFR 820, ISO 13485 and AS9100.

       Resolve technical issues: Participate in complaint, CAPA, NCR investigations, gather product conformity information, and coordinate with internal and external stakeholders to optimize product quality. Working within a cross-functional team, ensure that insufficiently developed processes are remediated, work instructions are updated, and scrap is minimized.

       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 updated 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. 

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.

QUALIFICATIONS

Education and Training

       BS degree in engineering or related field.

Experience

       2-5 years of related work experience in regulated, cGMP environment such as medical device, pharmaceuticals, or aerospace.

 Knowledge, Skills & Abilities

       Production Quality assurance experience supporting product development and/or manufacturing are preferred.

       Working knowledge of cGMP, ISO 13485 Quality System and/or AS9100.

       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 and writing technical documentation.

       Certification as a Quality Engineer (CQE) or Reliability Engineer (CRE) granted through the American Society of Quality (ASQ) preferred.

Compensation and Benefits

       Salary Range: $80,000 - $91,700 annually (Salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignment with market data.

       In addition to a salary, this position is eligible for an annual bonus based upon company performance.

       3D Systems offers a comprehensive benefit package including medical, dental, and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance.  Flex (Vacation) Time, Sick Leave, FAMLI Leave, Parental Leave, and 9 holidays per year are provided as paid time off. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match. Educational assistance and supplemental health and life plans are available.

Applications will be accepted online through February 29, 2024.