Quality Technician

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage. Cardiothoracic surgeons are adopting AtriCure‚ s ablation products for the treatment of AF during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 33 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has not cleared or approved certain AtriCure products for the treatment of AF or a reduction in the risk of stroke.

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.

ROLES AND RESPONSIBILITIES:

  • Ensure all appropriate activities are within scope of established procedures and quality management system requirements compliant to FDA regulations, MDD, CMDR, and ISO requirements

  • Assist quality engineering in the execution and completion of nonconforming product reports (NCRs, investigations, corrective and preventive actions (CAPAs), and supplier NCRs/CAPAs in support of ongoing manufacturing

  • Direct and/or support Suppliers, Engineering, Inspection, Calibration, Quality Engineering and Document Control

  • Work closely with others within the Quality department and other departments in support of daily quality and/or manufacturing activities

  • Serve as a back-up for Quality Inspectors in support of incoming, in-process, and/or finished goods inspection as needed

  • Perform activities in support of manufacturing/quality compliance such as device requisitions for real-time aging, equipment handling, dock-to-stock, and demo device conversion

  • Demonstrate negotiation and problem solving skills

  • 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

BASIC QUALIFICATIONS:

  • Experience with inspection/testing and data analysis

  • Strong computer/data entry, report writing, and communication skills

  • Problem solving/trouble shooting experience

  • FDA and ISO Audit experience helpful

  • Ability to read technical specifications, blue prints, and drawings helpful

PREFERRED QUALIFICATIONS:

  • Bachelor‚ s/Associate‚ s degree or equivalent

  • FDA QSR and ISO 13485 knowledge

  • MDD, CMDR, and JPAL knowledge

  • ASQ certification(s)

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement ‚ i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %; O=Occasional, R=Regularly, N=Never):

  • Regularly walk, sit, and stand

  • Occasionally bend and push/pull

  • Occasionally lift over 25 pounds

  • 25% travel possibility

  • Position dependent upon candidate passing pre-employment physical/drug screen

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.




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