Analyst, QA (Complaints)

This role is responsible for complaint trending, product performance quality presentation and complete Preventive Risk Assessment (PRA) for trend evaluation of complaints, for Breast Implants and Electromechanical Medical Devices (EMD). 

MAJOR RESPONSIBILITIES

• Responsible for complaint trending and product quality review, which includes evaluating “as reported” complaints signals and conducting failure analysis on “as analyzed” complaint investigations in PRAs for Breast Implants and EMDs.
• Review the historical records of medical devices and document them properly in the system.
• Request the required documents from the appropriate personnel to carry out the review of DHRs and FIs.
• Support the process of reviewing the records of medical devices by identifying opportunities for improvement.
• Maintain constant communication with the Post Market Quality Assurance department to fulfill the requested requirements. Additionally, communicate with the Device Analysis Laboratory if needed, should any requirements arise.
• Host monthly Product Performance meeting to present product return data, complaint trending and confirmed failure analysis.
• Support OMR preparation material for DHR and DAL info. 
• Ensure regulatory compliance of activities carried out in the work area: applicable Procedures, Standards, and Regulations.
• Guarantee compliance with corporate and legal EHS (Environmental, Health and Safety) requirements by adhering to internal policies and procedures. Likewise, ensure compliance through the adoption of strategies, internal controls, communication, and necessary training
• Carry out all other duties inherent to the position and those assigned by the immediate supervisor.