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Spec 2, Complaint Mgmt
Ref No.: 18-29296
Location: San Diego, California
Job Title: Complaints Specialist
Location: San Diego, CA, 92121
Duration: 12 Months


Job Summary :

Responsible for the completion of all tasks associated with the project for the complaint files remediation that include reviewing complaint records, electronic complaint record updates, and contacting customers for complaint associated information.


DUTIES & RESPONSIBILITIES

This job description does not promise or imply that the functions & responsibilities listed are the only duties or responsibilities to be performed or that the position may not change or be eliminated. Employees are always expected to follow their supervisors' instructions and to perform the tasks requested by their supervisors.

Duties & Responsibilities include any of the following as assigned by your Supervisor:

• Collaborate with appropriate clinical, technical, and/or regulatory employees to determine the scope of the project and level of the file remediation
• Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for Client products
• Coordinate and prepare project updates throughout the project
• Comply with the site Quality System

Performs other duties as assigned.

Minimum Qualifications

Associates degree or high school education preferred: a minimum of 1 year experience in
  • Quality, Regulatory or Complaint management; or equivalent combination of education and experience.
  • Working knowledge of QA in a medical device industry.
  • Good English grammar and writing skills.
  • Attention to details and complete documentation.
  • Time management skills, adherance to schedules
  • Able to utilize computers for development of reports and summary of project experience
  • including word processing, graphics and spreadsheet computer applications such as Microsoft Word, PowerPoint and Excel.
  • Prior work with TrackWise Complaint Handling System or equivalent electronic complaint database preferred.
  • Ability to work on multiple files with various disciplines are essential. Position requires ability to solve problems and meet deadlines