Complaint Quality Approver

• Review complaint records throughout the investigation lifecycle and provides the final Quality approval before record closure.
• Confirms alignment on investigation strategy, Root Cause Analysis (RCA) is appropriate.
• Ensure the appropriate investigation tools are used, and that the right stakeholders are involved, including consideration of end-to-end supply chain factors as applicable. During execution, the approver supports the investigation owner by reviewing updates, requesting clarification or additional evidence, and ensuring new information and follow-up narratives are accurately integrated into the complaint (PQMS) record, including any actions required based on new information.
• Confirms risks are identified, managed and escalated, and supports actions as required.
• Prior to approval, the approver verifies data integrity and that conclusions (including RCA) are supported by objective evidence, confirms trending and recurrence considerations are addressed, and ensures the investigation summary and outcome are clear and aligned across sites/affiliates when applicable.
• Provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution.
• Verifies required actions (including NC, when applicable) are defined, owned, and appropriately tracked before approving the complaint record.

• Must be able to effectively operate in a matrixed environment and interact with cross functional local and global leaders on a regular basis.

• Complaint investigation owner(s) and cross-functional contributor (e.g., Manufacturing, QC, Engineering, Supply Chain, Packaging, MSAT).

• Other sites and affiliates (as applicable) to align investigation strategy, evidence, and outcome for site-manufactured product complaints.

• Quality leadership for escalation, risk communication, and decision alignment.

• External manufacturers/partners and laboratories (as applicable) to obtain and evaluate investigation input and analytical results.

We are searching for the best talent for a Complaint Quality Approver to be located in Gurabo, PR.

The Complaint Quality Approver is accountable for independent, objective review and approval of complaint records to ensure investigations are complete, scientifically justified, and compliant with applicable procedures and regulations. The role confirms that risk is assessed, root cause and actions are adequately supported by evidence, required stakeholders are involved, and the complaint record can be closed with a clear and consistent outcome.