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Quality Technician

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AtriCure
Published
April 19, 2022
Location
Mason, Ohio, ohio
Job Type

Description

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.

POSITION SUMMARY:

The Quality Technician is responsible for a variety of activities to support the Quality department such as providing support to quality engineering and inspection as needed, partnering with manufacturing with daily production needs, and ensuring compliance to domestic and international regulatory requirements.

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Ensure all appropriate activities are within scope of established procedures and quality management system requirements compliant to FDA regulations, MDD, CMDR, and ISO requirements
  • Support Engineering, Inspection, Equipment and Calibration, with daily activities including Inspection, First Article inspection, Equipment Review, Documentation Updates, and Complaint Investigation.
  • Serve as a back-up for Quality Inspectors in support of incoming, in-process, and/or finished goods inspection as needed
  • Demonstrate problem solving skills for root cause investigation, corrective/preventative action and process/inspection improvement projects as needed.
  • Assist with FDA and ISO audits
  • Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts
  • Familiar with domestic and international standards and controls which are job-related
  • Generally, operates with appreciable latitude for actions and/or decisions on day-to-day activities. Receives or seeks guidance on novel or controversial problems that may impact the business significantly
  • Other duties as necessary and assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • 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

BASIC QUALIFICATIONS:

  • 1-3 years experience with mechanical inspection of machined and molded components.
  • Strong computer/data entry, data analysis, report writing, and communication skills
  • Problem solving/trouble shooting experience
  • FDA and ISO Audit experience helpful
  • Ability to read technical specifications, blueprints, and drawings
  • High School Diploma or Equivalent

PREFERRED QUALIFICATIONS:

  • Bachelor’s/Associate’s degree or equivalent
  • Basic understanding of GD&T, First Article Inspection, PPAP and Inspection Layout
  • CMM (Polyworks) and/or Smartscope (MeasureMind 3D) Inspection/Programming Experience
  • FDA QSR and ISO 13485 knowledge
  • MDD, CMDR, and JPAL knowledge
  • ASQ certification(s)

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pull
  • Ability to regularly lift up to 25 pounds
  • Ability to pass pre-employment drug screen and background check
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).

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