Overview

Requisition ID: 7180 Job Title: Principal Quality Systems Engineer, QMS - Alpharetta, GA Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. For more information, visit . Essential Duties and Responsibilities: The Principal Quality Systems Engineer - QMS serves as a senior subject matter expert and strategic contributor in the development, execution, and continuous improvement of critical Quality System processes. This position bridges high-level strategy with hands-on implementation, ensuring robust compliance, risk management, and operational efficiency across areas such as Quality System Strategic Planning (QSSP), Management Review, Corrective and Preventive Actions (CAPA), customer complaints handling, laboratory nonconformances and improvements, specification control, and sustainability-related change management. This position leads the QMS integration during mergers and acquisitions. This individual leads cross-functional initiatives, drives quality system harmonization, and serves as the process owner /and process owner support of one or more core elements of the Quality Management System (QMS), contributing to regulatory inspection readiness and the advancement of quality culture throughout the organization. Key Responsibilities: Serve as a business process owner or support and senior technical lead for key QMS elements (e.g., QSSP, Management Review, CAPA, customer complaints handling,health authorities reportability, recalls, change control, specification management, etc.). Lead and mentor teams in complex root cause investigations and development of effective corrective and preventive actions. Partner with stakeholders to drive quality improvements tied to customer complaints and product issues across the lifecycle. Develop and/or analyze quality metrics to monitor process health, effectiveness, and compliance. Collaborate with management to support audit readiness, regulatory inspections, and gap remediation activities. Ensure alignment of quality system elements with sustainability and product lifecycle strategies. Subject Matter / trainer for QMS and regulatory expectations. Evaluates new or revised documents of external origin applicable to the Quality Management System and supports the development of action plans to close identified gaps. Supports quality management in the review and approval of CAPAs, change orders, procedures, work instructions, customer complaints, health authorities reporting, recalls and any other applicable quality system documents. Leads the QMS integration during mergers and acquisitions. Supports and/or leads the quality organization in the implementation of project initiatives inclusive of QSSPs. Serves as a quality reviewer, approver and consultant for corporate laboratories in the areas of laboratory nonconformances, CAPA, procedures, test methods, validation and any other applicable documen