Quality Systems Compliance Specialist -

Medical Device Date Posted:

5 October 2026

Closing Date:

November 4, 2026

Recruiter:

Avanos Medical Location:

Alpharetta, Georgia Salary:

USD95,000

to

USD125,000

Job Type & Industry:

Compliance, Technology Risk Contract Type:

Permanent Job Reference:

3005082561-2 Apply for this job now Job Description 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. Responsibilities 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 Required Skills Quality management systems (QMS)

FDA 21 CFR 820

compliance

ISO 13485

compliance Internal auditing CAPA management Nonconformance investigation Risk management/FMEAQuality metrics and data analysis Technical writing and documentation control Medical device regulatory knowledge