Quality Assurance

Brief Statement of Duties / Work to be performed:

• Handles customer feedback (complaints) and ensures all complaints are processed in a uniform and timely manner.
• Assess all reported information or complaints and determines whether a complaint is a reportable event under different regulations.
• Coordinates with sales branches to obtain pertinent information related to the complaint.
• Facilitates the investigation and prepares investigation report and answer card for all complaints.
• Conducts necessary evaluation through simulations and visual inspection of the actual and retention samples related to complaint.
• Facilitates Health Hazard Evaluations (HHE) for Production Origin complaints to determine actions on the product already in the market affected by the non-conformity.
• Review corresponding Adverse Event Report (MedWatch Report (MDR), Mandatory Problem Report (CMDR) and EU Vigilance Report) prior sending to respective...