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3D Systems Quality Engineer - Personalized Healthcare Services (PHS) - in Littleton, Colorado

JOB SUMMARYThe 3D Systems site in Littleton, Colorado is looking for a skilled QualityEngineer to partner with our Personalized Healthcare Services (PHS) teamunder the direction of the Quality Assurance Manager. The PHS team provides 3Dprinted patient-specific devices (models, guides, templates) toimprove the quality of peoples' lives. This position will directly impactproduct through use of Quality knowledge and expertise.Performance ObjectivesThe following performance objectives will determine job success for thisposition:Develop and Improve Product Quality Processes : Utilize existingprocesses, inspection methods, and augment capabilities with processes tomeet and customer requirements. Specify, develop, and implement newmethods for ensuring the quality of product produced at 3D Systems. Managecorrective and preventive actions for continual improvement of internal andcustomer processes.Product and Process Requirements : Participate in project meetings and leadefforts to translate and understand part, project, and validationrequirements.Resolve technical issues: Work with cross-functional teams to identify,investigate, correct, and mitigate issues affecting product. Managenonconforming product reports, deviations, and complaints for product.Perform Batch Release : Review device history records, ensure complianceto predetermined specifications, and generate product releasedocumentation, including certificates of analysis and conformity.Process and Product Validation : Participate in cross functional team todevelop and execute test protocols for the verification and validation of newproducts, materials, equipment, software, and processes. Performstatistical analysis of data to assess viability of product designs andmanufacturing processes.Perform Measurement System Analysis : Identify and evaluate measurementsystems to ensure accuracy, precision and stability used to assess productconformity.This document represents the major duties, responsibilities, andauthorities of this job, and is not intended to be a complete list of alltasks and functions. It should be understood, therefore, that incumbentsmay be asked to perform job-related duties beyond those explicitly described.Education and TrainingBS degree in engineering or related fieldExperience1-2 years of related work experience in regulated, cGMP environment such asmedical device, pharmaceutical or food manufacture.Knowledge, Skills and AbilitiesQuality assurance and reliability experience supporting product developmentand/or manufacturing are preferred.Working knowledge of cGMP and ISO 13485 Quality SystemAbility to read and understand specifications across a number of products andmaterials.Ability to analyze and develop engineering processes for use in advancedtechnology implementations.Experience in preparing technical documentation.A successful candidate for this position will be a U.S. PersonEqual OpportunityEmployer-minorities/females/veterans/individuals withdisabilities/sexual orientation/gender identity

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