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Employer: SterilMed, Inc

Job Title: Senior Quality Engineer

Job Code: A011.7755

Job Location: Plymouth, MN

Job Type: Full-Time

Job Duties: Develop measurement systems to monitor the effectiveness of QA and reliability systems to identify, bracket, correct, and prevent defects, demonstrating continuous improvement to management. Provide support and expertise in the implementation and enforcement of GMP, ISO, and FDA requirements, and maintain alertness to changes in the industry and regulatory environments, applying this information to business practices. Prepare QA systems and 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 the defined QA program for product transfers. Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for manufacturing, technical services, and product development to minimize sample and scrap waste, assess reliability and risks based on data presented, identify root causes of problems, and reduce and identify sources of variation. Audit and approve manufacturing, quality, engineering, and validation/qualification documents for conformance to company business practices and departmental procedures. Support the development of validation strategies and act as a liaison to the Regulatory Affairs department to perform initial regulatory reviews of all engineering changes/modifications to products. Perform analysis of documents and information to ensure that all critical product characteristics have been identified and properly evaluated, including design specifications, FMEA (Failure Mode Evaluation and Analysis) for product and process material specifications, QA system (in-line control points) - FGI results, product inquiry analysis, reliability analysis, and R& D Laboratory support. Provide sampling plans and approve inspection methods for evaluation and testing of components and products. Support the Continuous Release program, where applicable, to reduce the need for FGI inspection, and provide support and expertise in reliability strategy and reliability growth demonstration during new product development.

Requirements: Employer will accept a Master's degree in Biomedical Engineering, Systems Engineering, Quality Engineering Management, Business Management, or related field, and three years of experience in job offered or in a Senior Quality Engineer -related occupation.

This job posting is anticipated to close on 8/11/2025.

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