Mdr Complaint Handling Specialist - Irvine, United States - Infosoft Teksolutions

Infosoft Teksolutions
Infosoft Teksolutions
Verified Company
Irvine, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
Here are the job position details for your review:

Job Title
:
MDR Complaint Handling Specialist

Pay Rate
:
$35 to $39/HR
Duration
:12 months

Location
:
Irvine, CA
We are looking for
MDR Complaint Handling Specialist
The main function of a
MDR Complaint Handling Specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate


Responsibilities:


  • Manage customer relationships and expectations during the course of the
    complaint
    investigation and resolution process
  • Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering, and other departments/business units for complaint investigations
-
Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA:

  • Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable
    root causes, resolve open action items, and gather additional technical information to resolve the complaint

Skills:


  • Experience working in a
    medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
  • Proven expertise in MS Office Suite and ability to operate general office machinery

Education and Experience:


  • Bachelor's Degree or equivalent in a related field
  • 1+ year of experience required

Job Type:
Contract


Pay:
$ $39.00 per hour

Expected hours: 40 per week


Experience level:

  • 1 year

Schedule:

  • 8 hour shift

Work setting:

  • Inperson

Ability to Commute:

  • Irvine, CA required)

Ability to Relocate:

  • Irvine, CA 92614: Relocate before starting work (required)

Work Location:
In person
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