Associate Quality SpecialistCincinnati, OH; Mason, OH

POSITION SUMMARY

The Associate Quality Specialist will execute and maintain Unique Device Identification (UDI) compliance activities for AtriCure products. This role manages UDI data across global regulatory systems, supports regulatory change assessments, and coordinates with internal teams, external regulatory agencies, and third‑party partners to ensure accurate, complete, and timely UDI submissions.

ESSENTIAL FUNCTIONS OF THE POSITION

Collaborate cross‑functionally to support global UDI compliance activities. Perform UDI data entry, verification, and ongoing maintenance within Regulatory Information Management Systems (RIMS). Manage and maintain Global Data to ensure accuracy of UDI documentation internally. Evaluate and provide input to Change Request Plan (ChRP) UDI impact assessments. Interface with external regulatory agencies and third‑party contractors to support external UDI data registration. Manage and maintain UDI‑related data within external UDI systems to ensure accuracy. Support data entry and ongoing maintenance for emerging UDI requirements in new jurisdictions, including EU, Australia, Colombia, Singapore, China, Brazil, and Switzerland. Support resolution of UDI‑related requests and questions from internal stakeholders to reduce process bottlenecks. Assess UDI activities for compliance with AtriCure Quality System requirements, applicable global regulations, and company policies and identify gaps. Participate in audit‑related activities for internal and/or external audits, as necessary. Support additional Quality System activities and special projects as assigned.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION

Demonstrate reliable, consistent, and predictable work performance. Apply strong organizational and data‑management skills to maintain accuracy and efficiency. Thriving in a fast‑paced environment with the ability to adapt to changing priorities. Communicate effectively, both verbally and in writing, across all levels of the organization. Seek guidance from peers or management as appropriate to resolve problems or conflicts. Prioritize multiple tasks and manage competing deadlines effectively. Collaborate productively with cross‑functional teams and stakeholders. Ability to successfully work with others. Perform additional duties and responsibilities as assigned. This hybrid position requires regular in‑office attendance to support collaboration and business needs.

BASIC QUALIFICATIONS

Entry‑level position; 0–2 years of relevant experience. Associate’s degree in a relevant major or equivalent experience in Quality, Regulatory, or similar role in a regulated industry. Experience with data entry and working within structured systems or databases. Foundational knowledge of medical device quality systems or regulatory requirements. Proficiency in computer applications and strong attention to detail.

PREFERRED QUALIFICATIONS

Bachelor’s degree in Business, Biosciences, Engineering, or related discipline, or equivalent experience. Familiarity with global UDI requirements and regulatory data systems. Experience with systems such as RimSYS, GUDID, GDSN, or similar platforms. Ability to read and interpret technical or regulatory documentation.

OTHER REQUIREMENTS

Ability to regularly walk, sit, or stand as needed. Ability to occasionally bend and push/pull as needed. Ability to pass pre‑employment drug screen and background check. Ability to sit at a desk for extended periods of time. Ability to look at a computer screen for extended periods of time. Ability to occasionally lift up to 25 pounds.

BENEFITS

We offer medical and dental coverage beginning day one, 401(k) with matching, 30 days of paid parental leave, volunteer time off, pet insurance, a corporate fitness center and cafeteria, and more. Full details are available on our careers website.

EEO STATEMENT

AtriCure participates in the federal E‑Verify program and is an Equal Employment Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, disability, sexual orientation, gender identity, or any other characteristic protected by law. #J-18808-Ljbffr AtriCure