Design Quality Engineer – Lifecore Biomedical, LLC is seeking a Design Quality Engineer to join its MS&T team in Chaska, Minnesota. This full-time position provides quality engineering expertise to support process and equipment validation, new business development, and customer interactions during new product development activities. The role applies Quality by Design (QbD) principles and effective risk management to ensure products, processes, equipment, and systems meet quality and regulatory requirements. Responsibilities include leading quality system activities related to equipment, systems, and manufacturing processes (validation, report generation, investigations, process trending); providing quality engineering support for new process development, technology transfer, and equipment or facility qualification projects; developing validation strategies based on product risk, process understanding, and regulatory requirements; reviewing and approving controlled documentation including validation protocols and reports, production-related documents, nonconformities, validation deviations, and other quality records; qualifying new equipment, facility changes, utilities, and manufacturing processes through IQ/OQ/PQ/PPQ activities; establishing, analyzing, and monitoring process trends, performance metrics, and process capability data; facilitating risk assessments related to quality systems, new process development, process improvements, and product changes; reviewing and approving Change Orders to ensure appropriate assessment of quality and regulatory impact; and partnerin

Design Quality Engineer – Lifecore Biomedical, LLC is seeking a Design Quality Engineer to join its MS&T team in Chaska, Minnesota. This full-time position provides quality engineering expertise to support process and equipment validation, new business development, and customer interactions during new product development activities. The role applies Quality by Design (QbD) principles and effective risk management to ensure products, processes, equipment, and systems meet quality and regulatory requirements. Responsibilities include leading quality system activities related to equipment, systems, and manufacturing processes (validation, report generation, investigations, process trending); providing quality engineering support for new process development, technology transfer, and equipment or facility qualification projects; developing validation strategies based on product risk, process understanding, and regulatory requirements; reviewing and approving controlled documentation including validation protocols and reports, production-related documents, nonconformities, validation deviations, and other quality records; qualifying new equipment, facility changes, utilities, and manufacturing processes through IQ/OQ/PQ/PPQ activities; establishing, analyzing, and monitoring process trends, performance metrics, and process capability data; facilitating risk assessments related to quality systems, new process development, process improvements, and product changes; reviewing and approving Change Orders to ensure appropriate assessment of quality and regulatory impact; and partnerin