Senior Quality Systems Engineer

Essential Duties And Responsibilities

The Senior Quality Systems Engineer – CAPA & Compliance is responsible for leading and maintaining the effectiveness of the Corrective and Preventive Action (CAPA) system and ensuring ongoing compliance with applicable global regulatory requirements and quality standards. This role plays a critical part in driving continuous improvement, ensuring robust root cause analysis, and maintaining audit readiness across the organization.

• Act as a subject matter expert (SME) for CAPA, non‑conforming product, deviations (quality non‑conformance) and compliance‑related activities.
• Lead the end‑to‑end CAPA, non‑conforming product and deviations (quality non‑conformance) processes, including initiation, investigation, root cause analysis, action planning, implementation, and effectiveness verification.
• Ensure CAPA activities are compliant with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Review and approve CAPA records to ensure completeness, accuracy, and timeliness. Coordinate CAPA Review Board, publish meeting minutes and ensure actions are completed on a timely manner.
• Monitor CAPA metrics and quality data source trends to identify systemic issues and drive continuous improvement. Own and/or support the quality data trending process.
• 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.

• 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.

• 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 decision‑making.
• 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.

• Master’s degree preferred.
• 7+ years of experience in quality systems, quality engineering, or regulatory compliance within a regulated industry (medical device, pharmaceutical, etc.).
• 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., Track Wise, Master Control, ETQ) and Microsoft Office Suite.
• Lean Six Sigma certification (Green Belt or higher).

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.