Medical Device Quality Engineer

Avanos Medical seeks a Quality Engineer to ensure our respiratory, digestive, and pain management solutions meet the highest safety and performance standards. In this role, you will lead validation, verification, and risk management activities, support design control and CAPA, and collaborate with R&D, manufacturing, and regulatory teams. You will analyze quality metrics, drive root cause analysis, and support continuous improvement initiatives in a regulated environment aligned with FDA and ISO 13485 requirements, helping deliver better outcomes for patients and caregivers worldwide.

Responsibilities

• Lead quality engineering activities for medical devices supporting pain and chronic care therapies
• Develop and execute validation, verification, and risk management protocols to meet regulatory standards
• Support design control, CAPA, and complaint investigations to drive product and process improvements
• Collaborate cross-functionally with R&D, manufacturing, and regulatory teams on new product development and changes
• Analyze quality metrics, conduct root cause analysis, and implement corrective and preventive actions
• Ensure compliance with FDA, ISO 13485, and internal quality system requirements
• Prepare and maintain technical documentation, test reports, and traceability records
• Partner with suppliers and operations to improve incoming, in-process, and final product quality
• Contribute to continuous improvement, lean, and Six Sigma initiatives across quality processes
• Support internal and external audits and provide quality engineering guidance to project teams

Required Skills

• Quality engineering
• Design controls
• Risk management (ISO 14971)
• Process validation and verification
• Root cause analysis
• CAPA management
• Statistical analysis (Minitab or similar)
• ISO 13485 quality systems
• Regulatory compliance (FDA 21 CFR 820)
• Documentation and technical writing