Hiring: Quality Engineer I Company: Resonetics Location: Hutchinson, MN Job Posted Time: 2026-09-14 12:50:27 Target Skills & Keywords : R, Risk Management, Six Sigma About the job Experience: •2+ years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience. Required Skills: •Demonstrates strong proficiency in applying various tools and methods to identify and realize new product or process introductions (ex. QMS, product related), and business improvements. •Leads and contributes to the application of various risk management and risk mitigation tools and practices. •Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions. •Conducts and supports the development of test methods in equipment, process, and product qualifications/validations. •Develops, implements, and/or maintains process Quality control plans are in accordance with product risk level and are followed. •Develops, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling). •Supports all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820. •Participates in design/technical reviews as appropriate. Qualifications: •0-2+ years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience. •Demonstrated capacity to create job-related documentation for quality purposes. •Demonstrated technical writing and communication skills. •Solid functional working knowledge of Statistical software and/or Minitab. •Bachelor’s degree or equivalent experience. •Operational familiarity with ISO 13485 standards and 21 CFR 820 regulations. •CQE and/or Six Sigma Green or Black belt. •BS degree: Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred. •Strong attention to detail and satisfactory organizational skills. •Able to self-manage project tasks 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!