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Senior Supplier Quality Engineer
3 months ago
Senior Supplier Quality Engineer
Mason, OH, USA Req #2140 Wednesday, June 26, 2024 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 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.
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. 4 years 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.
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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, 20 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: 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 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).
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