Hybrid Quality Document Control Manager – Lead & Compliance

Avanos-Medica; Alpharetta (GA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Benefits on day 1

Free onsite gym

Onsite cafeteria

HQ region voted best place to live

Job summary

Avanos Medical in Alpharetta, GA seeks a talented Manager of Quality Document Control to lead the global document control function and ensure QMS documents, records, and data comply with FDA and ISO requirements. The role oversees the EDMS, drives lifecycle management, and partners with multiple functions to support audit readiness.

The position requires 5–7 years in quality document control, leadership experience, and strong regulatory knowledge, with hybrid in-office scheduling in Alpharetta.

Qualifications

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

Responsibilities

• Manage day-to-day operations of Document Control (creation, review, approval, issuance, revision, obsolescence).
• Administer and maintain the EDMS with audit trails and access controls.
• Ensure compliance of documents with regulatory requirements and internal procedures.
• Lead and develop document control staff with performance management and training.
• Collaborate with Quality, Regulatory, Manufacturing, Engineering, and R&D on change control and document revisions.
• Establish KPIs for cycle times, backlog, and on-time completion.

Skills

Quality systems knowledge

Leadership / people management

Regulatory knowledge (FDA ISO)

Analytical communication

Education

Bachelor's degree in a scientific, engineering, or related technical field

Tools

EDMS software (ETQ MasterControl Veeva Vault)

Job description

Avanos Medical in Alpharetta, GA seeks a talented Manager of Quality Document Control to lead the global document control function and ensure QMS documents, records, and data comply with FDA and ISO requirements. The role oversees the EDMS, drives lifecycle management, and partners with multiple functions to support audit readiness.

The position requires 5–7 years in quality document control, leadership experience, and strong regulatory knowledge, with hybrid in-office scheduling in Alpharetta.