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3D Systems Senior, QA Engineer - 2100001P in Littleton, Colorado

Quality Engineer III - VA ProjectThe 3D Systems site in Littleton, Colorado is looking for a skilled QualityEngineer III to partner with our 3D Systems Quality team and the VA to helpset up a new Quality Management System across the hospital network to supportmedical manufacturing at different facilities and improve treatments for USVeteran patients. This individual will also assist with design controls,production and post-production activities.Performance Objectives:The following performance objectives will determine job success for thisposition:Conduct Process and Product Validation: Participate in cross functionalteams to develop and execute test protocols for the verification andvalidation of new products, materials, equipment, software, andprocesses. Perform statistical analysis of data to assess viability of productdesigns and manufacturing processes.Quality Management System: Participate in the creation, execution,maintenance and improvement of the Quality Management System in accordancewith the requirements of USFDA CFR 820 and ISO 13485.Develop Product Quality Processes: Utilize 3D Systems existing processes andinspection methods and modify as needed to meet technical requirements ofmedical devices manufactured at VA hospitals.Perform Measurement System Analysis: Identify and evaluate measurementsystems to ensure accuracy, precision and stability used to assess productconformity.Resolve technical issues: Participate in complaint investigations, gatherproduct conformity information, and coordinate with internal and externalstakeholders to optimize product quality.Qualify New Suppliers: Evaluate new candidate suppliers to ensure they meetthe operational and quality needs of 3D Systems as governed by applicableregulatory bodies such as the FDA.Facilitate Design Control Process : Following internal procedures forproduct and process development, participate in the transfer of new projectsinto Manufacturing. Ensure that all required quality documentation is completeand released.QualificationsEducation and TrainingBS degree in engineering or related fieldCertification as a Quality Engineer (CQE) or Reliability Engineer(CRE) granted through the American Society of Quality (ASQ) preferredExperience4-8 years of experience in a Quality Engineering role, or an equivalentcombination of education and experience.Knowledge, Skills, and AbilitiesWorking knowledge of cGMP and ISO 13485 Quality SystemExcellent analytical, negotiation, and problem resolution skills are arequirement.High level of competency in TQM, Six Sigma programs, DOEs, and wellversed in Lean Thinking.Ability to evaluate, prioritize and problem solve a variety of tasks toensure their timely and accurate completion.Ability to analyze and develop engineering processes for use in advancedtechnology implementations.Ability to communicate effectively, both verbally and in writing, with awide variety of internal and external customers.Travel is required, up to 25% of the time.Compensation and BenefitsSalary Range: $81,700-122,500 (salary to be determined by theeducation, experience, knowledge, skills, and abilities of thecandidate, and alignment with market data)In addition to a salary, this position is eligible for an annual bonus basedupon company performance.3D Systems offers a comprehensive benefit package including medical, dentaland vision coverage, company-paid short-term and long-term disabilityinsurance, and company-paid basic life insurance. Sick Leave, Flex(Vacation) Time, Parental Leave, and paid time off for recognizedholidays. 3D Systems also provides a 401(k) Retirement Savings Plan optionwith a company match.Equal OpportunityEmployer-minorities/females/veterans/individuals withdisabilities/sexual orientation/gender identity

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