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Quality Operations Specialist

Cincinnati, OH, USA Req #649
Friday, May 27, 2022
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 activities related to finished goods testing and on-going monitoring of product to support continued released of finished product. Additionally, the role may be trained for monitoring the performance of the Controlled Environment(s) and utilities such as the DI Water System(s), Compressed Air System(s) and other functionalities to support the Environmental Monitoring Program.

 

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Assist in the collection of finished products for submission of products for Bacterial Endotoxin Testing to support product release.
  • Manage the collection of finished products for execution of routine product bioburden testing and quarterly dose audits.
  • Compile test results that support sterilization of finished product to facilitate release of product for saleable inventory.
  • Monitor results and manage facilitation of questions, issues and variances that occur related to sterilization and finished product testing.
  • Generate non-conformance reports as necessary and support investigations related to sterilization, product release or environmental monitoring.
  • Collect, compile, and report results through monthly metrics, trend reports, and dashboards
  • Document and generate reports for routine bioburden and dose audit studies.
  • Assist in the compilation of devices and/or data related to sterilization validation work as guided by Product Sterilization Specialist or management.
  • Execution of sampling for controlled manufacturing areas via contact plates, impact plates, and a particle counter.
  • Collection of water samples and monitoring of water systems for compliance to specifications
  • Submission of environmental monitoring samples to 3rd party test lab(s)
  • Coordination of  3rd party suppliers to execute HEPA filter pressure certification for controlled manufacturing areas and sampling of compressed air systems
  • Document and generate reports for routine Environmental Monitoring and Product Testing.
  • Support team with remediation, and quality system tasks including investigations, CAPAs, etc.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable work performance
  • Flexible schedule – some weekend work as needed
  • 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:

  • High school diploma required or demonstrated equivalent combination of education, training and experience
  • Working experience in regulated environment, with familiarity to cGMPs, 1 year minimum
  • Computer/data entry skills
  • Written/report writing skills
  • Good interpersonal skills
  • Verbal communication skills
  • Intermediate Microsoft Office skills (Excel, Word, PowerPoint)
  • Problem solving skills
  • Ability to prioritize multiple projects
  • Travel up to 10%

   PREFERRED QUALIFICATIONS:

  • Associates Degree
  • Strong understanding of cGMPs
  • Knowledge of aseptic technique

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as needed
  • Ability to occasionally bend and push/pull as needed
  • Ability to regularly lift up to 25 pounds, occasionally lift up to 50 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, 15 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/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).

Other details

  • Job Family Quality Technician
  • Job Function Quality
  • Pay Type Hourly
  • Employment Indicator Non Manager