Quality Inspector

AtriCure • Mason, OH

12d • Onsite

About The Position

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. 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. The Quality Inspector is responsible for ensuring that incoming components, in-process material, and final products are inspected properly and comply with applicable specifications. Inspections are performed using a variety of mechanical and electrical inspection equipment as required by inspection instructions. The Quality Inspector is responsible for all documentation required by the quality system, and ensuring all documentation is complete and accurate. The Quality Inspector has the authority to deem product acceptable as well as reporting non-conforming product.

Requirements

• High School Graduate or equivalent
• Experience with inspection/testing equipment and gages
• Ability to read technical specifications, blue prints and drawings
• Strong computer/data entry, report writing, and communication skills
• Problem solving/trouble shooting experience
• Specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
• Ability to regularly walk, sit, or stand as required
• Ability to occasionally bend and push/pull
• Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
• Ability to pass pre-employment drug screen and background check

Nice To Haves

• ASQ, CQI, or CQT Certification
• Working Knowledge of GD&T
• Experience with OGP SmartScope (Operation, Programming)
• Experience in the Medical Device industry
• FDA, QSR and ISO 13485 knowledge

Responsibilities

• Inspection of incoming material, in-process material and final product and packaging per AtriCure Quality Systems procedures
• Completion of inspection data and other documentation necessary to release materials to internal and external operations or inventory
• Reporting non-conforming materials and initiating a Non-Conformance Report when required per AtriCure’s Quality Systems procedures
• Performing First Article Inspections
• Supporting rework activities as required by AtriCure’s Quality Systems procedures
• Perform testing as required by Product Development and Quality Engineering
• Ensure all appropriate activities are within compliance to AtriCure’s Quality System and Company Policies, FDA regulations, and ISO requirements
• Other duties as necessary and assigned by the Quality Supervisor
• 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
• Additional duties as assigned

Benefits

• Medical & Dental beginning day 1 of employment
• 401K plus match
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
• Volunteer Time off
• Pet Insurance
• On-site fitness center
• On-site cafeteria

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED