Quality Document Control Lead | Hybrid (Alpharetta)

Avanos Medical; Alpharetta (GA); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Free onsite gym

Onsite cafeteria

Total rewards benefits

Job summary

Avanos Medical, headquartered in Alpharetta, GA, is seeking a Manager of Quality Document Control to lead global document control for the QMS, ensuring controlled documents, records and data are created, reviewed, and retained in compliance with FDA and ISO requirements. The role oversees an EDMS and a team of coordinators across Quality, Regulatory, Manufacturing, Engineering and R&D.

The position focuses on audit readiness, regulatory inspections, and continuous improvement of document control

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical field or equivalent experience.
• 5–7 years in Quality Document Control, Quality Systems, or Quality Assurance in regulated industry.
• 4+ years leading or supervising a team.
• Working knowledge of FDA regulations (21 CFR Part 820/211) and ISO 13485.
• Proficiency with EDMS and quality management software.

Responsibilities

• Manage day-to-day operations of the Document Control function including creation, review, approval, issuance, revision and obsolescence.
• Administer and maintain the EDMS with appropriate access controls and audit trails.
• Ensure compliance with regulatory requirements and internal procedures.
• Lead and develop document control staff with workload planning and performance management.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering and R&D on change control and document lifecycle.

Skills

Leadership

Regulatory knowledge

Communication

Analytical thinking

Education

Bachelor's degree in science/engineering

Tools

ETQ

MasterControl

Veeva Vault QualityDocs

Job description

Avanos Medical, headquartered in Alpharetta, GA, is seeking a Manager of Quality Document Control to lead global document control for the QMS, ensuring controlled documents, records and data are created, reviewed, and retained in compliance with FDA and ISO requirements. The role oversees an EDMS and a team of coordinators across Quality, Regulatory, Manufacturing, Engineering and R&D.

The position focuses on audit readiness, regulatory inspections, and continuous improvement of document control