Quality Systems Coordinator

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 AtriCure.com 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.

POSITION SUMMARY:

This position will be responsible for assisting in the maintenance of the validated state of the Quality System and work on project teams that enhance AtriCure's Quality System (QMS). They will participate in audits of the QMS and ensure externally identified changes are appropriately executed through AtriCure's processes.

ESSENTIAL FUNCTIONS OF THE POSITION:

• 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.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• 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

BASIC QUALIFICATIONS:

• 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

PREFERRED QUALIFICATIONS:

• 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.

OTHER REQUIREMENTS:

• 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

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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: https://www.atricure.com/careers-atricure/benefits. 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 https://www.e-verify.gov/ 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).