Quality Systems Compliance Specialist - Medical Device

Quality Systems Compliance Specialist Avanos Medical seeks a Quality Systems Compliance Specialist to support and enhance our global medical device quality system. In this role, you will maintain compliance with FDA, ISO 13485, and other regulatory requirements by managing quality documentation, change control, and internal audit activities. You will investigate nonconformances, support CAPA and risk management, and partner with cross-functional teams to drive continuous improvement.

The specialist will analyze quality metrics, prepare inspection-ready records, support regulatory inspections, and train staff on quality procedures, helping ensure safe, effective products for patients worldwide.

• Maintain and improve the quality management system in alignment with FDA and ISO 13485 requirements
• Manage quality documentation, records, and change control processes
• Plan, execute, and support internal quality audits and readiness for external inspections
• Investigate quality events and nonconformances and support CAPA activities
• Support risk management, including FMEA and related quality risk assessments
• Analyze quality metrics and trends to identify and drive continuous improvement opportunities
• Collaborate with cross-functional teams on quality and compliance initiatives
• Train and coach employees on quality system procedures and best practices
• Prepare and maintain inspection-ready documentation for regulatory agencies
• Ensure compliance with global medical device regulations and company standards

• Quality management systems (QMS)
• FDA 21 CFR 820 compliance
• ISO 13485 compliance
• Internal auditing
• CAPA management
• Nonconformance investigation
• Risk management/FMEA
• Quality metrics and data analysis
• Technical writing and documentation control
• Medical device regulatory knowledge