3D Systems, Inc. Senior, QA Engineer in Littleton, Colorado
Quality Engineer III - VA Project
The 3D Systems site in Littleton, Colorado is looking for a skilled Quality Engineer III to partner with our 3D Systems Quality team and the VA to help set up a new Quality Management System across the hospital network to support medical manufacturing at different facilities and improve treatments for US Veteran patients. This individual will also assist with design controls, production and post-production activities.
The following performance objectives will determine job success for this position:
Conduct Process and Product Validation: Participate in cross functional teams 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.
Quality Management System: Participate in the creation, execution, maintenance and improvement of the Quality Management System in accordance with the requirements of USFDA CFR 820 and ISO 13485.
Develop Product Quality Processes: Utilize 3D Systems existing processes and inspection methods and modify as needed to meet technical requirements of medical devices manufactured at VA hospitals.
Perform Measurement System Analysis: Identify and evaluate measurement systems to ensure accuracy, precision and stability used to assess product conformity.
Resolve technical issues: Participate in complaint investigations, gather product conformity information, and coordinate with internal and external stakeholders to optimize product quality.
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.
Education and Training
BS degree in engineering or related field
Certification as a Quality Engineer (CQE) or Reliability Engineer (CRE) granted through the American Society of Quality (ASQ) preferred
- 4-8 years of experience in a Quality Engineering role, or an equivalent combination of education and experience.
Knowledge, Skills, & Abilities
Working knowledge of cGMP and ISO 13485 Quality System
Excellent analytical, negotiation, and problem resolution skills are a requirement.
High level of competency in TQM, Six Sigma programs, DOEs, and well versed in Lean Thinking.
Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion.
Ability to analyze and develop engineering processes for use in advanced technology implementations.
Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers.
Travel is required, up to 25% of the time.
*Compensation and Benefits*
Salary Range: $81,700-122,500 (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. Sick Leave, Flex (Vacation) Time, Parental Leave, and paid time off for recognized holidays. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.
Title: Senior, QA Engineer
Requisition ID: 2100001P