Quality Systems Engineer - (Job Number: 0808929)

Quality Systems Engineer - (Job Number: 0808929) DescriptionEthicon Endo- Surgery, Inc., a member of Johnson && Johnson's Family of Companies, is currently recruiting for a Quality Systems Engineer located in Albuquerque, NM. Ethicon Endo-Surgery, Inc.- develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure- enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastro-intestinal health, gynecology and surgical oncology. The Quality Systems Engineers are responsible for product team support of quality system design and audit of steady state manufacturing processes. They will conduct audits to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) && any other applicable standards and providing compliance assessment && status. They will also prepare, conduct, monitor and report on audits of all ETHICON ENDO-SURGERY quality system categories to assess compliance to GMP, ISO && EES standards. Develop measurement systems, which monitor effectiveness of QA && Reliability systems to identify, bracket, correct and prevent defects to demonstrate continuous improvement to management. Maintain alertness to changes in the industry && regulatory environments and apply this information to business practices at EES. Provide support and expertise in the implementation and enforcement of GMP, ISO && FDA (Food && Drug Administration) requirements. Prepare QA (Quality Assurance) system && assist in technical issues for manufacturing processes that are to be transferred to satellite facilities. Manage established processes in support of steady state manufacturing in accordance with defined QA program for product transfers. Provide statistical support && expertise in DOE (Design of Experiments) && analytical problem solving for manufacturing, technical services and product development in order to: Minimize sample and scrap waste, assess reliability && risks based on data presented, identify root cause of problems and reduce/identify sources of variation. Audit and approve manufacturing, quality, engineering and validation/qualification documents for conformance to ETHICON ENDO SURGERY business practices and departmental procedures. Support development of validation strategy. Act as liaison to Regulatory Affairs department to perform initial regulatory review of all engineering changes/modifications to products. Perform analysis of documents/information to insure that all critical product characteristics have been identified and properly evaluated: Design specification, FMEA (Failure Mode Evaluation && Analysis): Product && Process, Material Specification, FGI I Sheet / P-Sheet, QA system (in line control points), FGI results, Product inquiry analysis and Reliability analysis. Provide sampling plans and approve inspection, methods for evaluation/testing of components and products. Support Continuous Release program, where applicable to reduce need for FGI inspection. Support program to eliminate Post Cobalt FGI Audit Testing for product release. Provide expertise in reliability strategy and growth demonstration during new product development. A minimum of a Bachelor's Degree is required. It is preferred that the degree be in mechanical, electrical or industrial engineering. A CQE, CRE, CQA 2 rating would also be preferred. It is required that the candidate have a minimum of 5 years manufacturing engineering or quality experience, with some exposure to supplier management. Experience in auditing for compliance to ISO or GMP standards in the medical device/pharmaceutical area would be preferred. FDA Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification) is required. Statistics knowledge is preferred. Knowledge of gage reliability and repeatability theory and application is required. Excellent communication, negotiation and partnership skills are required. Up to 30% travel is required. Apply Now