Hiring: Quality Engineer-250111 Company: Medix™ Location: Eden Prairie, MN Job Posted Time: 2026-09-16 14:20:40 About the job Experience: •Solid understanding of Quality System requirements as outlined in FDA 21 CFR Part 820 and ISO 13485, with the ability to translate and communicate regulatory requirements to cross-functional partners. Required Skills: •Support incoming material receiving and inspection Support materials receiving and inspection activities including preparation, inspection, and disposition of incoming materials. •Ensure quality of produced products by understanding production process, reviewing batch record documentation, and performing/reviewing in-process and finished goods inspections •Assist in the release of sterile products by reviewing sterilization results, labeling products, and addressing any non-conformance. •Assist in analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformance, audit observations) •Support controlled facilities environment by participating in environmental monitoring, calibration, and preventive maintenance activities •Perform equipment qualification for any new and changing equipment requirements •Generate and evaluate metrics that are used to identify negative trends and areas for improvement and inspecting products returned from the field •Participate with a cross-functional team on field complaint investigations Qualifications: •Bachelor's (BS) or advanced degree in an engineering or technical discipline. Open to new graduates! Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!