Senior Supplier Quality Engineer

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. Position Summary 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. Essential Functions Of The Position Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metricsDirect and support supplier-related activities, including:QMS qualification and monitoring including supplier audits and assessmentsComponent (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.Supplier change requests and improvementWork closely with Quality Management, Product Development, and other departments in developing and executing company strategiesAble to support both New Product Development activities at suppliers as well as sustaining activities for existing components and subassemblies.Able to work cross-functionally, overcome challenges, and facilitate cooperation with suppliers to meet regulatory requirementsAssist with FDA and ISO audits. Perform internal and supplier audits as necessaryStrong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this positionOperates with appreciable latitude for, and assumes ownership of, actions and/or decisions on day-to-day activities.Determines appropriate response to novel or controversial problems that may impact the business significantlyUses knowledge of best practices and technical proficiency in supplier quality engineering to mentor junior SQE’s. Other duties as necessary and assigned Additional Essential Functions Of The Position Regular and predictable work performanceAbility to work under fast-paced conditionsAbility to make decisions and use good judgmentAbility to prioritize various duties and multitask as requiredAbility to successfully work with othersAdditional duties as assigned Basic Qualifications Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.4+ years of experienceFDA and ISO 13485 knowledge and audit experienceWillingness to travelExperience with inspection/testing and data analysisStrong computer/data entry, report writing, and communication skillsDetails-oriented with strong problem solving/trouble shooting experienceMust be able to read technical specifications, blueprints, and drawingsEngineering/design backgroundAbility to travel 25% Preferred Qualifications MDD, CMDR and JPAL knowledgeASQ Certified Quality EngineerASQ Certified Quality Auditor or ISO13485 Lead Auditor certificationStatistical use experienceExperience with Metal Injection Molding (MIM) suppliers Other Requirements Ability to regularly walk, sit, or stand as neededAbility to occasionally bend and push/pull as neededAbility to regularly lift up to 25 pounds, occasionally lift over 25 poundsAbility to pass pre-employment drug screen and background check AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s). You may access our global privacy policy here: https://www.atricure.com/privacy