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Senior Complaints Analyst/ Complaint Specialist (Medical Device)

Company: Covetus, LLC
Location: Irvine
Posted on: February 15, 2020

Job Description:

Job Title : Sr Complaints Analyst Location : Irvine, California and 92618 and Fontana, California 92335 Type : Full-Time Job Description : Business Intelligence and Data analytics (Tableau, Spotfire), SAS, Python Medical device Complaints, Data analytics, regulatory and compliance environment. Bachelor's (or higher) degree in Mechanical Engineering / Bachelor's (or higher) degree in Computer Science or equivalent relevant work experience (required). Minimum 5 years of experience in QA - Medical device Complaints, Data analytics regulatory and compliance environment. Project and communication management Establish and maintain complete complaint files and databases for all client complaints, according to established company procedures. Maintenance of all complaint procedures, files and records according to established Cryoport procedures. Establish and maintain quality metrics for all product complaints, according to the direction of the Manager. Metrics may include complaints by product type, reason for complaint, customer, or specific time periods. Coordination with complaint investigation and analysis personnel to understand root cause analysis in support of documentation to properly close the complaint. Perform investigation, approval and closure activities for complaints as per company procedures, unless otherwise mentioned. Ensures quality of complaint records Applies analytical skills to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements, Anticipates and prevents potential issues with external teams, Provides guidance and technical advice Evaluates subject matter expert assessments, Escalates potential Quality issues to Management - provided by Dice

Keywords: Covetus, LLC, Irvine , Senior Complaints Analyst/ Complaint Specialist (Medical Device), Healthcare , Irvine, California

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