Associate Quality Specialist

POSITION SUMMARY:

The Associate Quality Specialist will execute and maintain Unique Device Identification (UDI) compliance activities for AtriCure products. This role is responsible for managing UDI data across global regulatory systems, supporting regulatory change assessments, and coordinating with internal teams, external regulatory agencies, and third-party partners to ensure the accuracy, completeness, and timeliness of UDI submissions. The position collaborates cross-functionally to ensure adherence to global UDI requirements and supports ongoing compliance efforts related to evolving global UDI requirements.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Collaborate cross-functionally to support global Unique Device Identification (UDI) compliance activities for AtriCure products
• 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 inputto 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 any 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
• Thrive in a fast-paced environment with the ability to adapt to changing priorities
• Communicate effectively, both verbal and in writing, across all levels of the organization
• Seeks guidance from peers or management as appropriate to resolve problems/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 cross-functional collaboration and business needs

BASIC QUALIFICATIONS:

• Entry-level position; 0–2 years of relevant experience preferred
• 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 preferred
• 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 such systems as RimSYS, GUDID, GDSN, or similar platforms (internship or entry-level experience acceptable)
• 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

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