Sr Engineer Sterilization

Job Description

General Objective:

This position supports and coordinates Quality Engineering and Quality Assurance functions, integrating engineering principles and quality management to drive continuous improvement initiatives, including Ethylene Oxide process as well as projects focused on enhancing overall quality performance. Ensures compliance with applicable regulatory requirements and standards, while supporting the maintenance of the quality management system. Collaborates closely with Maintenance, Operations, and EHS to implement continuous process and quality initiatives, along with corrective and preventive action (CAPA) activities related to EO process and customer requirements. Supports internal and external audits as required. 

Responsabilities:

• Manage and qualify NLDC vendors, including EO and pest control services and other external services
• Execute IQ/OQ/PQ validations in compliance with FDA and ISO...