Quality Engineer
AtriCure, Inc. - United States
Hiring: Quality Engineer Company: AtriCure, Inc. Location: United States Job Posted Time: 2026-09-15 11:45:34 Employment Type: Contract / Hybrid Target Skills & Keywords : Lean Manufacturing, Product Lifecycle Management, R, Regulatory Compliance, Risk Management About the job Experience: •Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kaizen, etc. a plus •Strong interpersonal, organizational, and communication skills. •Metrology, auditing and data analysis experience •Knowledge of EO and Gamma sterilization processes. Required Skills: •Provides daily Quality Engineering support of manufacturing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of product line issues through correction and prevention processes. •With respect to direct line responsibility, the QE manages, and coordinates required activities from functions (ie. Engineering, Manufacturing, Supplier Quality, Inspection, Document Control) and processes (ie. NCR, Investigation, FMEAs, Rework, Deviations, CAPA) •Chairs the MRB for respective product line. •Leads and/or supports risk management activities including risk assessments, pFMEAs, health hazard evaluations, and implementation of risk control measures throughout the product lifecycle. •Analyzes quality metrics, manufacturing trends, and process performance indicators to identify risks and drive improvement initiatives with cross-functional peers. •Contributes to new product development and transfer by supporting Design Assurance (and NPD Teams) as required. Examples would include inspection/control plan development and the establishment of compliant production and process controls during production transfer •Leads and/or supports protocol development, execution, review and approval activities for process validation, equipment qualification, test method validation, and manufacturing line transfers. •Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable. Qualifications: •Bachelor’s degree required in Engineering or demonstrated equivalent combination of education, training and experience. •2 - 5 years of experience in a process, manufacturing, or quality engineering role. •Able to interpret design drawings (including GD&T) and product specifications •Measurement System Analysis (Gage R&R) experience a plus •MDD, MDR, CMDR and JPAL knowledge •Demonstrated capacity to regularly walk, sit, or stand as needed •Demonstrated capacity to occasionally bend and push/pull as needed •Demonstrated capacity to pass pre-employment drug screen and background check •AtriCure participates in the federal 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!