Summary: This role supports Quality Engineering and Assurance, integrating engineering principles to drive continuous improvement, ensure regulatory compliance, and maintain the quality management system. Highlights: 1. Drives continuous improvement initiatives and ensures regulatory compliance. 2. Collaborates across departments for process and quality enhancements. 3. Executes validations and maintains robust risk management. **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 requirements. Facilitates and maintains FMEA documentation to ensure robust risk management. * Provide data\-driven reports on quality trends. * Update documents in ETQ Reliance as needed to reflect current practices. * Support on internal/external audits as required. * Review and approve change control * Evaluate customer complaints and work in root cause and corrective actions for complaints * Oversee preventive maintenance and calibration documentation * Revise and evaluate key performance indicators and data trends by applying statistical methods for CAPA opening decision. * Support the implementation and improvements for Good Manufacturing Practices (GMPs). * Ownership for Quality Projects within the department and collaborate with other departments. * Provide Quality Engineering support to Operations, Maintenance and EHS. Support Production Operation by Identifying in\-process opportunities and implement solutions to drive continuous improvement through CAPA system. * **Comunications:** * Ensure strategic alignment and communication with the Corporate Sterilization QA team. * Maintain effective interdepartmental communication to ensure operational alignment. * Support internal departments by addressing inquiries related to Quality Systems. * Facilitate technical training and onboarding for new sterilization engineers. * Provide cross\-functional support to Maintenance and Operations for equipment, process implementations and operational excellence. * Provide data\-driven insights on quality performance and trends. **Health and Safety:** Collaborate with the EHS department to ensure compliance with EO handling protocols. Maintain strict compliance with PPE requirements during all on\-site activities. Adhere to EHS workplace safety guidelines and protocols. Maintain 5S standards to ensure an organized and efficient quality work environment. Ensure strict compliance with EHS regulations while executing quality\-related projects and activities. **Organization, plan and control:** Schedule the annual validation schedule in accordance with procedures/FDA/ISO. Contribute to cross\-functional programs and corporate initiatives as required. Define and execute continuous improvement strategies to enhance overall quality and reduce operational costs. **Technical skills:** * Knowledge in ISO13485\. * Experience in medical devices. * English Intermediate/Advanced. **Experience:** * Minimum of 11 years in quality/engineering experience. **Softskills:** * Strong leadership. * Self driven * Management Skills * Oriented to results * Effective communications **Scolarship:** * Bachelor Degree (Engineering preferable). **Key internal and external relationships:** **Internal** * Operations * EHS * Maintenance **External** External Auditors Intermal Auditors Corporate Sterility Assurance Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.