Quality Document Control Manager - Hybrid, Audit-Ready

Avanos Medical; Alpharetta (GA); Hybrid; USD 95,000 - 135,000; 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 Manager of Quality Document Control to lead global document control within the QMS. You will manage controlled documents, records, and data to ensure regulatory compliance and audit readiness across R&D, Manufacturing, Quality, and Regulatory Affairs.

You will oversee EDMS operations, implement improvements, and mentor a team of document control professionals to maintain product quality and patient safety in a hybrid, in-office schedule.

Qualifications

• Bachelor's degree in a scientific, engineering, or related technical field or equivalent experience.
• Minimum 5-7 years in Quality Document Control, Quality Systems, or Quality Assurance in regulated environments.
• 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.
• Strong organizational, analytical, and communication skills.

Responsibilities

• Manage day-to-day operations of Document Control: creation, review, approval, issuance, revision, obsolescence.
• Administer and maintain the EDMS with proper access controls and audit trails.
• Ensure controlled documents and records comply with regulatory requirements and internal procedures.
• Lead, coach, and develop document control staff.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, and R&D on change control and document revision cycles.
• Establish KPIs for cycle times, backlog, and on-time completion.
• Support audits and regulatory inspections with timely document retrieval.
• Drive continuous improvements to document control workflows.

Skills

Organizational skills

Analytical skills

Communication skills

Education

Bachelor's degree in scientific/engineering field

Tools

EDMS platforms (ETQ, MasterControl)

Quality management software

Job description

Avanos Medical in Alpharetta, GA, seeks a Manager of Quality Document Control to lead global document control within the QMS. You will manage controlled documents, records, and data to ensure regulatory compliance and audit readiness across R&D, Manufacturing, Quality, and Regulatory Affairs.

You will oversee EDMS operations, implement improvements, and mentor a team of document control professionals to maintain product quality and patient safety in a hybrid, in-office schedule.