Quality Complaint Contractor

Job Title: Quality Complaint Contractor
Location: San Diego, CA - onsite
Duration: 6 Months+
Pay Rate: $31/Hr on w2
Shift: 1st Shift
 

• Regularly monitors Complaint Handling inbox for new complaints and adverse event reports
• Generates complaints in the eQMS and adds data inputs to Master Complaint Tracker
• Attaches all relevant files and reports for the complaint to the eQMS e.g. PC/AE reports, Follow-Up communications, Reportability Assessments, log files etc.
• Organizes and generates Complaint folders in SharePoint to help with investigations and collaboration activities
• Performs DHR review for Complaint investigations
• Updates Complaint investigation summary with administrative information including complaint number, PC/AE report information, Device information etc.

 
Requirements:

• Knowledge of QSR’s and their application
• Complaint handling experience
• Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
• Ability to manage multiple responsibilities with a high degree of self-motivation
• Good written, oral, and interpersonal English communication skills
• Ability to use Microsoft Word and Excel applications

 
Notes:
This is a fully on-site position
This position is open to cover a worker on a leave of absence so currently this will be a firm 6-month position, however, if the candidate shows strength and the budget warrants, they may be considered to extend or convert, however, there is no guarantee.

• MUST be strong with Excel, Word, SharePoint
• Knowledge and experience using Electronic Quality Management System (OMNIFY) is helpful but will be taught so not required.
• Is this post-market complaint handling - YES
• Education - college degree OR experience in complaint handling - both preferred
• Is this a drug or medical device product - DEVICE
• How many complaints on average per day - 5
• The manager will first conduct a phone interview and if interested will then conduct an in-person interview.

 
Remarks:

• Minimum 1-3 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience
• BS/BA degree in scientific discipline desired

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