Complaint Handling Coordinator AccessClosure

SUMMARY/RESPONSIBILITIES:

SUMMARY: Execution of tasks pertaining to all aspects of the Complaint Handling process, including activities involved in the Returned Material Authorization (RMA) process, while maintaining compliance with applicable Quality System requirements and FDA regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Provide support to the Complaint Handling team and assure timely and accurate input and completion of complaints into the Complaint Handling database (EasyTrak)
Intake of Complaints via phone calls, email and/or fax
Utilize EasyTrak and other databases for data entry, report generation, and trending analysis
Responsible for the Return Material Authorization (RMA) process, including:
o Initiate Return Material Authorization for product return, and coordinate with the sites and field personnel to expedite the return as required
o Notify Quality and Receiving of upcoming return, and coordinate with Customer Service regarding warranty replacement if required
Initiate, prepare, and distribute reports related to product complaints
May provide backup / support to the Quality Engineering Technician on an ad-hoc or as-needed basis (i.e. basic visual inspections, decontaminating devices, etc.)
Perform other tasks as assigned

EDUCATION/EXPERIENCE:

AA Degree and 2 + years experience in the medical device/pharmaceutical field or related area
Clear and effective communication skills
Excellent interpersonal and organizational skills
Proficiency in MS Word, PowerPoint, and Excel required
Strong proofreading, editing, and technical writing skills
Ability to work within strict deadlines, and work on multiple projects accurately and efficiently
High attention to detail and accuracy is required

WORK ENVIRONMENT:

Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Work includes potential exposure to chemicals.

SUPERVISORY RESPONSIBILITIES:

No direct supervisory responsibilities.

Location:	Mountain View, CA United States