AtriCure
Associate Quality Specialist
Cincinnati, OH; Mason, OH · Junior · Internship
Sponsorship not specifiedDetected 21 days ago
FDA RegulatoryMedical DevicesCollaboration
About the role
- Evaluate and provide inputto Change Request Plan (ChRP) UDI impact assessments
- Participate in audit-related activities for internal and/or external audits, as necessary
- Demonstrate reliable, consistent, and predictable work performance
Responsibilities
- The Associate Quality Specialist will execute and maintain Unique Device Identification (UDI) compliance activities for AtriCure products.
- Collaborate cross-functionally to support global Unique Device Identification (UDI) compliance activities for AtriCure products
- Manage and maintain Global Data to ensure accuracy of UDI documentation internally
- 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
- Support additional Quality System activities and special projects as assigned
- Prioritize multiple tasks and manage competing deadlines effectively
- Collaborate productively with cross-functional teams and stakeholders
Requirements
- 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
- Proficiency in computer applications and strong attention to detail
Nice to have
- Bachelor's degree in Business, Biosciences, Engineering, or related discipline, or equivalent experience
- 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
- Familiarity with global UDI requirements and regulatory data systems
- 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
Skills
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
- Afib affects more than 33 million people worldwide.
- 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.
- For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Benefits
- https://www.atricure.com/careers-atricure/benefits.
Company info
- Assess UDI activities for compliance with AtriCure Quality System requirements, applicable global regulations, and company policies and identify any gaps
Equal opportunity
- 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.
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This listing is sourced directly from AtriCure's careers page and normalized into a canonical job model.