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Complaint Handling Specialist

Company: iRhythm
Location: Cypress
Posted on: March 28, 2020

Job Description:

Position: Complaint Handling Specialist

Reports to: Manager, Quality Assurance

Location: Cypress, CA

Description:

iRhythm Technologies, Inc. is a is a publically held (Nasdaq: IRTC) medical device and healthcare information services company with a proven approach to long-term continuous monitoring that enables diagnosis earlier in the clinical pathway to improve patient outcomes and reduce healthcare costs. iRhythm provides competitive compensation and benefits package.

The Complaint Handling Specialist will support the growth and continuous improvement of the Complaint Quality System, providing hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day to day complaint review, investigation reports, adverse event reporting and complaints log and trend maintenance.

Responsibilities:


  • Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
  • Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
  • Reviews daily processes to ensure issues are being addressed and escalated in a timely manner
  • Maintains complaints log
  • Participates in process improvements



    • Perform other quality and regulatory-related duties as assigned


      Required Qualifications:


      • Bachelor's Degree
      • Minimum of 2 years of experience in Quality Assurance with complaint processing role.



        • Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD
        • Strong investigational and problem solving skills
        • Must work across functional teams within the organization
        • Attention to detail and timeliness are critical and a must
        • Excellent communication (verbal and written) and interpersonal skills required
        • Demonstrated experience with MS Word, Excel, Adobe Acrobat
        • Basic statistical methods including trend analysis
        • Must be able to work under minimum supervision and in a team environment.



          • Must be a positive and energetic team player


            This is a full time position. We offer an excellent benefit and salary package.

            This fast-paced company is looking for the right candidate to join us at this exciting time in our development. Qualified candidates should submit their resume including salary requirements to openings@irhythmtech.com

            FLSA Status: Exempt

            As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

            Make iRhythm your path forward.

Keywords: iRhythm, Cypress , Complaint Handling Specialist, Other , Cypress, California

Click here to apply!

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