Quality Engineer

Quality EngineerAs a Quality Engineer, you will play a critical role in new product introduction, process validation, and manufacturing transfer activities, partnering with engineering, operations, suppliers, and customers to bring products from development into commercial production.ResponsibilitiesRepresent Quality on cross-functional product development teams.Support design transfer and product commercialization activities.Review and approve specifications, validation protocols, engineering changes, and quality documentation.Lead or support IQ/OQ/PQ validation activities and process qualification efforts.Facilitate manufacturing transfers between sites, suppliers, and customers.Drive risk management activities including FMEAs and Control Plans.Partner with manufacturing and engineering teams to improve process capability and manufacturing readiness.Support supplier qualification, quality investigations, and continuous improvement initiatives.Ensure compliance with FDA regulations, quality systems, and applicable industry standards.QualificationsBachelor's degree in Engineering or related technical discipline.5+ years of Quality Engineering experience within medical device or regulated manufacturing environments.Experience with new product introduction, design transfer, process validation, and manufacturing transfers.Strong knowledge of FDA regulations, risk management, CAPA, SPC, FMEA, and root cause analysis tools.Proficiency with Minitab, JMP, or similar statistical software.Excellent communication, analytical, and project management skills.Preferred QualificationsMedical device CDMO or contract manufacturing experience.CQE, Lean Six Sigma, or related quality certifications.Knowledge of cleanroom operations, sterilization processes, and eQMS platforms.Experience with DOE, measurement system analysis, and process capability studies.Work EnvironmentOn-site role within a manufacturing and engineering environment. Occasional travel may be required to customer, supplier, or company locations. Exposure to production and plating areas requires adherence to safety and quality procedures.Job Type & LocationThis is a Permanent position based out of Anoka, MN.Pay and BenefitsThe pay range for this position is $95000.00 - $120000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. PTO, 401K match, and 10 Paid Holidays.Workplace TypeThis is a fully onsite position in Anoka, MN.Application DeadlineThis position is anticipated to close on Sep 6, 2026.