Description
SUMMARYAssist with the maintenance of quality systems and facilitate continuous quality improvements. This position is responsible for the maintenance and monitoring of a variety of cGMP documentation including complaint files, complaint processing system, investigations and closure, corrective action and preventive actions (CAPA), product investigations, Adverse event decision making, and maintenance of other related quality system records as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
*Review and evaluate complaints to ensure appropriate action and closure.
*Effectively supports complaint handling process and processes complaints/MDR & Vigilance in a uniform and timely manner
*Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and Part 806 Corrections and Removals, Canadian Regulations, European Vigilance Reporting and other regulatory requirements.
*Document and maintain records of all complaint investigations in accordance with 21CFR
*Complete all required customer complaint related documentation in an accurate, professional and timely manner.
*Prepare weekly and quarterly Metrics
*Effectively support clinical complaint handling process including serious adverse device effects (SADEs) and unanticipated adverse device effects (UADEs)
*Assist with the maintenance of quality systems and facilitate continuous quality improvements.
*Support internal, external, and third-party audits.
*Assume and perform other duties as assigned.
*Able to work flexible hours, including evenings, holidays and weekends. Overtime may be required.
If interested please forward me your resume and I will call you shortly.
To find out more about Real please visit www.realstaffing.com