Product Complaint Analyst II

Title: Product Complaint Analyst II

Pay: $40.00-$45.00/hr

Location: La Jolla, San Diego

Schedule: Hybrid (La Jolla based)

Duration: Initial 3-Month Contract (possibility for extension/conversion)

Summary

Participate in product quality activities related to complaint investigations for company products. Facilitate cross-functional discussions to identify, document, analyze, and report quality issues while ensuring customer feedback is appropriately evaluated. Support functional area initiatives and provide assistance to colleagues as needed.

Key Responsibilities

• Review individual cases and assess for potential adverse events requiring timely escalation to Regulatory Affairs.
• Review individual complaints, including assessment, investigation, and containment, to determine appropriate escalation.
• Ensure complaint records meet GMP standards, including documentation related to investigations, CAPA, and nonconformances.
• Participate in and perform tasks associated with rotational monitoring activities for the Quality Assurance escalation mailbox.
• Facilitate complaint evaluation activities, including assessment, investigation, containment, review, approval, and determination of ongoing needs.
• Participate in, facilitate, and/or support complaint investigations and resulting CAPA activities.
• Complete additional activities and responsibilities as assigned.

Listed responsibilities are essential but not exhaustive and represent the usual duties associated with the position. Individual responsibilities may change based on business needs.




Minimum Requirements

• Bachelor's degree.
• 1–3 years of recent experience in Quality or Regulatory Affairs within an in vitro diagnostics (IVD) or medical device company.

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