The Complaints Analyst will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards
Job Summary
The Complaints Analyst will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.
This individual will review documentation from incoming calls, faxes, and emails from all areas of the world and obtain adequate information to ensure proper documentation, investigation, and closure of each complaint.
The role involves evaluating information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
Matching Summary
The Complaints Analyst will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.
Skills & Requirements
Must-have
product complaint handling
regulatory reporting decisions
customer response letters
complaint database
quality management system concepts
Nice-to-have
influence and drive change
project management experience
process mapping experience
developed presentation skills
Key Requirements
BS in computer science, engineering, physical, biological, or natural sciences required
0 to 2 years of quality, manufacturing, or regulatory experience
familiar with good documentation practice (GDP)
familiar with corrective and preventive action (CAPA)
familiar with document change control practices
highly proficient in reading, writing, and speaking the English language
Experience with word processor software (e.g. Microsoft Word)
Experience with internet browsers (e.g. Internet Explorer)