Retrieve complaints from various database and update masterlist.
Accurately review, assess and process complaints in a uniform and timely manner.
Initial due diligence attempts to obtain complaint information and MDR checklist based on risk assessment criteria.
Review of technical complaint threshold report with complaint and perform escalated complaint(s) from various database into Trackwise System
Provide support to Product Quality Engineers to generate data for monthly PQT/CQT meeting
Participate in the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives.
Support and carry out quality initiatives program to address system inadequacies this may include quality programs, tracking, analyzing, reporting and problem solving.
Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.
Provide Product Quality Engineer and management with quality data and trends in product performance in meeting customer requirements by providing and monitoring of:
a) Product quality trend and address product issues.
b) Work with cross functional in evaluation and qualification of material and processes.
Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820 and OHSAS 18001 requirement.
Participate in quality escalation issues.
Support plant-wide activities and special projects, as assigned.