Senior Software Quality Engineer

Sr. Software Quality Engineer (Through April 2028 // Brooklyn Center, MN) Required Skills Experience with Software Validation for equipment used in production Experience using SPC, CAPA, NCMR, PDP processes Working knowledge of Quality System Regulations such as QSR 21 CFR 820, and ISO 13485:201 Excellent verbal and written communication, analytical, influencing, and interpersonal skill Education and Experience Education: Bachelor’s Degree in Software Engineering, Science or technical field. Experience: 4+ years of work experience in Engineering and/or Quality, or advanced degree with 2+ years of work experience in Engineering and/or Quality. Job Description In this exciting role as a Senior Software Quality Engineer within the Energy and Component team you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices within component manufacturing. This includes activities related to development, test method validation, process validation, inspection improvements, and process/quality change initiatives. Duties Provide Software Quality Engineering support for new product commercial medical device component manufacturing lines. Develop, modify, apply, and maintain quality standards and protocols for processing materials. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements. Present technical data to groups within the organization. Utilize quality tools including Risk analysis FMEA, statistical techniques such as six-sigma and DOE (design of experiments), root cause analysis, reading, and correcting drawings. #J-18808-Ljbffr