AtriCure, Inc. · 8 hours ago
Quality Systems Coordinator
Mason, OH
Full-time
Onsite
Mid Level
3+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Quality Systems Coordinator will assist in maintaining the validated state of the Quality System and work on project teams to enhance AtriCure’s Quality System, participating in audits and ensuring compliance with regulations.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Assists with special projects for the Quality System, including implementation of new regulations, product obsolescence and other projects identified throughout the lifecycle of commercialized product
Participate in cross-functional activities with input from Regulatory Affairs and commercial teams to ensure all requirements are understood and fulfilled when introducing a change to an existing system, regardless of geographic region
Participate in Quality Systems Internal Audits, including training to become certified as a lead QMS auditor
Support external Quality Systems Audits through functions such as backroom lead
Work directly with other functions of the Quality team to ensure needs are met and incorporated into any integration or expansion plans
Identify and lead continuous improvements through the AtriCure CAPA process
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
Qualification
Required
Bachelor's Degree in a scientific field
3-5 years of experience in a Medical Device or an equivalent regulated industry
Strong interpersonal, leadership, analytic and communication skills at multiple organizational levels
Strong communication skills (both verbal and written)
Attention to detail
Regular and predictable worksite attendance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Ability to regularly walk, sit, or stand as required
Ability to occasionally bend and push/pull
Ability to occasionally lift up to 25 pounds
Ability to pass pre-employment drug screen and background check
Preferred
Program Management Experience
Knowledge of regulatory requirements, including 21 CFR, ISO 13485, MDSAP, and EU MDR
CAPA or problem-solving experience
ISO 13485 and/or EU MDR certified Quality Auditor
Benefits
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
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
H1B Sponsorship
AtriCure, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (7)
2022 (10)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Company data provided by crunchbase