Product Complaint Analyst 2

Pay Rate: $36.25 $45.00/hour
Location: San Diego, CA 92122
Schedule: Hybrid
Duration: 2 month contract with potential to extend

Position Summary

We are seeking a Product Complaint Analyst 2 to support product quality and complaint investigation activities within a regulated medical device environment.

This position is responsible for evaluating product complaints, supporting investigations, identifying potential quality and safety issues, and ensuring complaint documentation meets applicable GMP and regulatory requirements. The Analyst will collaborate with Quality, Regulatory, and other cross-functional teams to ensure customer feedback and product quality concerns are appropriately evaluated, documented, investigated, and escalated.

Key Responsibilities

• Review product complaint cases and assess for potential adverse events requiring escalation to Regulatory Affairs.

• Evaluate complaints and support assessment, investigation, containment, and escalation activities.

• Ensure complaint records and investigations meet GMP and quality system requirements.

• Support and participate in complaint investigations, CAPA (Corrective and Preventive Action) activities, and nonconformance investigations.

• Facilitate cross-functional discussions related to product quality issues and complaint resolution.

• Review and approve complaint documentation and determine additional follow-up or investigation needs.

• Participate in rotational monitoring of the Quality Assurance escalation mailbox.

• Identify, document, analyze, and report product quality issues.

• Support Quality Assurance initiatives and other functional-area projects as needed.

• Perform additional quality-related responsibilities as assigned.

Minimum Qualifications

• Bachelor s degree required.

• 2 5 years of recent Quality and/or Regulatory Affairs experience.

• Experience must be within an in vitro diagnostic (IVD) or medical device company.

• Experience with product complaints and complaint investigations.

• Knowledge of GMP requirements and regulated quality systems.

• Experience supporting or working with CAPA, nonconformance, and investigation processes.

• Ability to identify potential adverse events and appropriately escalate cases to Regulatory.

• Strong documentation, analytical, communication, and cross-functional collaboration skills.

Preferred Background

Candidates with direct experience in medical device complaint handling, IVD products, Quality Assurance, Regulatory Affairs, CAPA, GMP, adverse event assessment, and product investigations are strongly preferred.