Job Description 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. Quality Assurance 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. Facilitate and maintain 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. Qualifications Minimum 11 years in Quality/engineering Experience Knowledge in ISO13485 Experience in medical devices English Intermediate/Advanced 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. #J-18808-Ljbffr