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AtriCure, Inc. has an opening for the Senior Supplier Quality Engineer position in Mason, OH. This position will be responsible for the development and implementation of supplier-related quality system requirements including compliance with international and domestic regulations in support of new product development, manufacturing, and quality management system activities with a focus on continuous improvement. Anticipated 20% domestic and 5% international travel to AtriCure sites and supplier sites. Duties include: · Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics. · Direct and support supplier-related activities, including: QMS qualification and monitoring including supplier audits and assessments; Component (and sub-assembly) qualification elements such as defining requirements and assessing First Articles, Measurement Systems, equipment and process qualifications, Control Plans, etc; Correction activities including managing NCRs and SCARs; and Supplier change requests and improvement. · Work closely with Quality Management and other departments in developing and executing company strategies. · Able to work cross-functionally, overcome challenges, and facilitate cooperation with suppliers to meet regulatory requirements. · Assist with FDA and ISO audits. · Perform internal and supplier audits as necessary. · Operate with appreciable latitude for, and assume ownership of, actions and/or decisions on day-to-day activities. · Determine appropriate response to novel or controversial problems that may impact the business significantly. · Use knowledge of best practices and technical proficiency in supplier quality engineering to mentor junior SQE's. Required: Bachelor's degree in Computer, Manufacturing, Biomedical, or Mechanical Engineering, or closely related field (foreign equiv. accepted) & 4 years of experience as an Engineer or closely related in the medical device industry. Also requires, 4 years of experience in each of the following: · Managing supplier relationships including qualifications, changes, nonconformances and corrections (NCR/SCAR/CAPA); and · Developing and executing IQ/OQ/PQ qualification protocols and reports. 6 months of experience required in: · Interpreting technical specifications, blueprints, and drawings; · Computer/data entry and report writing; · Inspection/testing and data analysis from FAIs and GR&Rs; and · Working cross-functionally with suppliers to meet quality requirements. Must have also participated in at least 1 quality audit -- both internally and with suppliers. Ability to pass pre-employment drug screen and background check is required. Experience may be gained concurrently. Applicants are directed to apply online at www.atricure.com (Req. 2140). No calls.