Complaint Analyst / Post-Market Quality Analyst

Role Summary:

• Support Post-Market Quality activities by investigating product complaints.
• Evaluate potential adverse events.
• Support complaint closure within the Quality Management System.

Key Responsibilities:

• Assess incoming product complaints and determine applicable failure modes.
• Perform detailed complaint investigations and document findings.
• Support testing and evaluation of returned products.

Risk Evaluation:

• Apply risk-based decision making.
• Identify potential product issues and support root cause analysis.

Cross-Functional Collaboration:

• Work with Manufacturing, Quality Engineering, R&D, Regulatory Affairs, and Clinical teams.
• Support investigations including CAPA, Non-Conformance Events (NCE), OOT investigations.