Senior Quality Systems Engineer

Requisition ID: 7063 Job Title: Senior Quality Systems Engineer Job Country: United States (US) Overview Avanos Medical is a medical device company focused on delivering clinically superior breakthrough solutions that help patients return to the things that matter. The company develops, manufactures and markets recognized brands in more than 90 countries. Avanos Medical is headquartered in Alpharetta, Georgia and is traded on the New York Stock Exchange (NYSE: AVNS). Essential Duties and Responsibilities The Senior Quality Systems Engineer – CAPA & Compliance leads and maintains the effectiveness of the Corrective and Preventive Action (CAPA) system and ensures ongoing compliance with applicable global regulatory requirements and quality standards. This role drives continuous improvement, robust root‑cause analysis, and audit readiness across the organization. Key Responsibilities Act as a subject‑matter expert (SME) for CAPA, non‑conforming product, deviations, and compliance‑related activities. Lead the end‑to‑end CAPA, non‑conforming product and deviation processes, including initiation, investigation, root‑cause analysis, action planning, implementation, and effectiveness verification. Ensure CAPA activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR). Review and approve CAPA records for completeness, accuracy, and timeliness; coordinate CAPA Review Board meetings, publish minutes, and ensure timely completion of actions. Monitor CAPA metrics and quality data trends to identify systemic issues and drive continuous improvement; own or support quality data‑trending processes. Facilitate cross‑functional CAPA review meetings and provide guidance on investigation techniques and problem‑solving methodologies. Implement and promote best practices in root‑cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis). Analyze quality data and trends to proactively identify risks and opportunities. Compliance & Quality Systems Drive improvements in quality system processes, particularly CAPA effectiveness and timeliness. Maintain compliance with global regulatory requirements and internal quality management system (QMS) procedures. Support internal and external audits, including FDA inspections, notified body audits, and customer audits. Lead or support responses to audit findings, including CAPA development and implementation. Ensure inspection readiness and support regulatory submissions as needed. Qualifications Required Bachelor's degree in engineering, Life Sciences, or a related technical field. Minimum of 5 years of experience in quality systems within the medical device or regulated industry. Strong experience managing CAPA systems and regulatory compliance activities. Strong data analysis and trending skills with the ability to interpret complex quality data, identify patterns, and drive data‑driven decisions. Comprehensive knowledge of FDA QSR, ISO 13485, EU MDR, and related quality system regulations and standards. Strong understanding of root‑cause analysis tools and risk management principles. Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience. Preferred Master's degree preferred. 7+ years of experience in quality systems, quality engineering, or regulatory compliance within a regulated industry. 2+ years of leadership or management experience in a quality systems role. Demonstrated success in leading quality system audits, managing CAPAs, and resolving complex quality issues. Exceptional leadership, interpersonal, and communication skills with the ability to influence at all levels of the organization. Proficient in eQMS platforms (e.g., TrackWise, MasterControl, ETQ) and Microsoft Office Suite. Lean Six Sigma certification (Green Belt or higher). Benefits Avanos offers a comprehensive and competitive Total Rewards package, including a salary, health care benefits, retirement plans, and work/life benefits. Equal Opportunity Employer Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. #J-18808-Ljbffr Avanos Medical