Job Description: Responsible for performing activities associated with the product complaint handling program.
Responsibilities: o Review initial complaint assessments for accuracy and completeness. o Review initial complaint for preliminary reportability assessment and determination of potential hazard o Work with departmental and interdepartmental personnel to ensure investigation activities yield the necessary information to determine the root cause of each complaint. o Provide root cause analysis for each complaint investigated. o Provide an assessment as to whether corrective or preventive action is required based on the outcome each complaint investigation. o Ensure customer complaints are being processed in a timely manner. o Ensure customer complaints are being processed in accordance with established company procedures and applicable regulatory standards. o Performs other duties as requested.
Requirements: o Bachelor's Degree in related field required. o 2+ years' experience in medical device industry or other FDA regulated industry. o Experience in failure analysis and scientific methodology will be required. o Prior working experience with complaint analysis or root cause determinations would be preferred. o Additional medical or statistical training/experience would be preferred. o Ability to manage multiple issues, be organized, and manage timely workflow is required. o Strong attention to detail and accuracy. o Must possess the ability to effectively communicate in written and oral format. o Must be a team-player, possess outstanding customer service skills and be self-motivated. o Acts with a sense of urgency, illustrates ambition and drives for completion of tasks and projects. o Must have the ability to initiative and develop creative solutions. o Possess the ability to manage time and prioritize critical priorities. o Must demonstrate the ability to increase knowledge. Education: o Bachelor's Degree in related field required. Schedule:
$18.66 to $26.12 DOE
343 MAIN ST
EL SEGUNDO, CA 90245