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QA Complaints Specialist II

San Diego, CA

Order: 227619
Temp - > 30 Hrs

Complaints Mgmt Specialist II

Pay: $25-33/hr.

Duration: 12+ Months Potential Long Term

Location: San Diego, CA 92121

Schedule: M-F 8-5 (may have some flex in start/end time by 1 hour)

 

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. Must be meticulous / detail oriented, agile, and have good documentation skills. Experience in a medical device or other highly regulated field and quality review/auditing are preferred.

Duties & Responsibilities

  • Collaborate with appropriate clinical, technical, and/or regulatory employees to understand the scope of the project and recognize the level of the file remediation

  • Assures timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD 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. Prefer Bachelor’s Degree.

  • Working knowledge of QA in a medical device industry.

  • Good English grammar and writing skills.

  • Attention to details and complete documentation.

  • Time management skills, adherence 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.