Quality Technician

Quality Technician
Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America
Req #2234
Monday, October 14, 2024
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. AtriCures Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCures AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCures Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCures 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 everyones 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:
The Primary Quality Technician, RMI is responsible for a variety of activities to support Production, Quality, Engineering and Product Development. This includes using a variety of mechanical and electrical inspection equipment, developing inspection methods and reviewing blueprints and technical specifications. This individual is responsible for all documentation required by the quality system, and ensuring all documentation is complete and accurate.
ESSENTIAL FUNCTIONS OF THE POSITION:
Ensures all appropriate activities are within compliance to AtriCures Quality System, Company policies, FDA regulations and ISO requirements
Complete First Article Inspections as requested
Assist in mentoring Quality Inspectors
Support Suppliers, Engineering, Inspection, and Equipment Calibration with daily activities including inspections, equipment review, documentation updates and complaint investigation.
Support the development of inspection methods for new product
Support the improvement of inspection efficiencies through automation and inspection method improvements
Review blueprints with Product Development and Engineering for accuracy and ability to inspect
Serve as a backup for the Quality Inspection team in support of incoming, in-process and/or finished goods inspection as needed
Supporting Rework activities as required by AtriCures Quality Systems procedures
Demonstrate problem solving skills for root cause investigation, corrective/preventative action, and process/inspection improvement projects
Support and prioritize projects, adapt to shifting priorities, work with moderate independence, able to resolve problems/conflicts
Assist with FDA, BSI and ISO audits.
Other duties as necessary and assigned
BASIC QUALIFICATIONS:
High School graduate or equivalent.
Ability to read technical specifications, blueprints, and drawings (ASME Y14.5 & ASME Y14.100)
4 years of advanced knowledge of GD&T (ASME Y14.5 1994 or greater) (Datums, Position, Flatness, Perpendicularity, Parallelism, Profile, Runout, and Material modifiers)
4 years of experience with common inspection/testing equipment and gauges (Ruler/Scale, Tape Measure, Calipers, Micrometers, Pin gauges, Drop/Dial Indicators, Height Gauge, etc.)
4 years of experience with advanced/uncommon inspection/testing equipment and gauges (Sine plate, Thread micrometer, universal micrometers, hardness tester, profilometer, durometer, etc.)
4 years of experience with pneumatic, electrical,