Primary Objective: SkyWater is actively seeking a Quality Assurance Engineer to join our dynamic team to support Wafer Services and Advanced Technology Services in Bloomington, MN. The role will be responsible for the definition, implementation, and improvement of Quality-related practices and procedures for the organization, principally as they relate to manufacturing process development and the associated business processes. The role will work closely with employees and customers to ensure products and processes meet specifications and standards. Major Areas of Accountability: * Evaluating production-readiness of programs and manufacturing processes currently under development. Generating relevant gap-analyses. * Aligning production expectations with development customers. * Provide corrective actions to nonconformities in their respective areas and verify the effectiveness of these actions. * Ensuring Quality management System requirements related to design and development are met for the certifications we hold (Ex, ISO 9001/ISO 13485/IATF 16949/AS9100). * Reviewing and approving project development-related documentation. * Reviewing and providing feedback on Risk Management tools such as FMEA. * Work on continuous improvement activities within their respective areas. * Work collaboratively with other departments. Required Qualifications: * BS in a STEM discipline or equivalent combination of education, training, and experience. * Minimum 4 years of Quality Assurance experience in a regulated environment or 2 years of New Product Introduction/New Product Development experience. * Skills: * Statistical Process Validation/Qualification or System Verification and Validation * Root Cause Analysis * Contract Fluency * Clear problem-solving capability with data-driven, systematic approaches to finding solutions. * Customer first mindset. * Demonstrated ability to meet commitments and deliver results. * Ability to manage and execute multiple projects simultaneously and shift priorities to meet business needs. * Ensures risks are escalated and documented appropriately. US Citizenship Required: This position will require the holding of or ability to obtain government security clearance which requires U.S Citizenship. Preferred Qualifications: * Understanding of new product development processes. * Knowledge of equipment used in the manufacture of semiconductor wafers is desired. * Ability to read and understand contracts, quality standards, and regulatory requirements. * Understanding of how to implement effective Corrective Action. * Knowledge of semiconductor manufacturing processes. * Certified auditor to one or more of the following standards (ISO 13485, ISO 9001, IATF 16949, and AS 9100) desired. Or * Understanding of the design and development-related sections of standards (ISO 13485, ISO 9001, IATF 16949, and AS 9100). * AIAG FMEA knowledge preferred. * Experience in reviewing contracts is desired. * PMP certification desired.