Product Quality Complaint Specialist

4 weeks ago


Lake Wales, Florida, United States Collabera Full time
Job Overview

Collabera is seeking a skilled Product Quality Complaint Specialist to join our team. This role is responsible for ensuring Product Quality Complaint (PQC) and Adverse Event Quality Investigation (AE-QIR) intake management processes comply with regulatory expectations.


Responsible for executing relevant procedures to ensure PQC and AE-QIR intake management processes comply with regulatory expectations.


Responsible for receipt, processing, and follow-up of Product Quality Complaints or Adverse Event Quality Investigation Requests.


Acts as an effective liaison between Organon support functions worldwide for complaint-handling activities to maintain regulatory compliance.


Provides expertise in complaint-handling processes and systems to resolve issues and drive continuous improvement.


Manages the intake of complaint samples for the US market. Identifies appropriate investigating sites, documents sample information, prepares the sample for shipment to the investigating site when designated by LCIU, performs functional testing, and documents all findings in the complaint records.


Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.



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