Quality Auditor

Work with Complaints Engineering Evaluations, develop Rood Cause Analysis, Analyze complaints trending for proper escalation (Product Risk Assessments).
Evaluate Risk Assessment (pFMEA, dFMEA) for customers complaints.
Provides documented evidence for disposition of the final assembled product through constant monitoring of the product and process by means of visual and physical inspections when required.
Performs final disposition, change status of raw materials, intermediates and finished material in the inventory system and physical in adherence to cGMP’s, company policies and procedures according to the product release lead-times.
Assures that all questionable material is quarantined and/or rejected.
Provides QA support to plant operations, Engineering Department, including troubleshooting, to assist in resolving quality-related problems.
Informs QO management of the status of operations and reports unusual situations and/or problems.
Reviews/issues applicable procedures and QSM’s according to QA manuals.
Maintains direct communication with other departments, such as Production, Procurement, Engineering, Logistics, among others.
Provides support to regulatory and compliance issues, including complaint investigations, annual review preparation, supplier audits, among others.
Responsible to obtain and report site QA metrics according to schedule.
Performs special projects as required and/or as assigned, as well as participates in meetings related with area of responsibility.
Complies with all environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any environmental events.
Provides support in the training process to new auditors on departmental practices and procedures.