Manager, Quality Document Control

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

Requisition ID:7266

Job Title:Manager, Quality Document Control

Job Country:United States (US)

Here at Avanos Medical, we passionately believe in three things:

• Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
• Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
• Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. For more information, visit www.avanos.com.

Summary

The Manager, Quality Document Control leads the document control function within the Quality organization, ensuring that controlled documents, records, and data supporting the Quality Management System (QMS) are created, reviewed, approved, distributed, revised, and retained in compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820/210/211, ISO 9001, ISO 13485) and internal procedures. This role manages the electronic document management system (EDMS), leads a team of document control staff, and partners cross-functionally to maintain audit-ready document control processes that safeguard product quality, patient safety, and regulatory compliance.

This position is responsible for global document control processes including management of controlled documents such as SOPs, work instructions, specifications, forms, drawings, and quality records. The role oversees a team of document control coordinators/specialists and works closely with Quality, Regulatory Affairs, Manufacturing, Engineering, and R&D to ensure timely, compliant document lifecycle management. Decisions made in this role directly impact audit readiness, regulatory inspection outcomes, and the overall integrity of the quality management system.

Responsibilities

• Manage day-to-day operations of the Document Control function, including document creation, review, approval, issuance, revision, and obsolescence processes.
• Administer and maintain the Electronic Document Management System (EDMS), ensuring system integrity, appropriate access controls, and accurate audit trails.
• Ensure controlled documents and quality records comply with applicable regulatory requirements (FDA 21 CFR Part 820/211,ISO 13485) and internal procedures.
• Lead, coach, and develop document control staff, including workload planning, performance management, and training.
• Partner with Quality, Regulatory Affairs, Manufacturing, Engineering, and R&D to support change control and document revision cycles.
• Establish and monitor key performance indicators (KPIs) for document control cycle times, backlog, and on-time completion rates.
• Support internal and external audits and regulatory inspections by ensuring timely, accurate retrieval of controlled documents and records.
• Drive continuous improvement initiatives to streamline document control workflows and reduce cycle times.
• Ensure proper archival, retention, and disposition of quality records in accordance with approved retention schedules.
• Develop, implement, and maintain document control procedures, work instructions, and training materials.
• Supports additional tasks such as quality data mining, and management representative communications processes.

Qualifications

Required:

• Bachelor's degree in a scientific, engineering, or related technical field, or equivalent combination of education and experience.
• Minimum of 5-7 years of experience in Quality Document Control, Quality Systems, or Quality Assurance within a regulated industry (e.g., medical device, pharmaceutical, or biotechnology).
• 4+ years of experience leading or supervising a team.
• Working knowledge of FDA regulations (21 CFR Part 820/211) and/or ISO 13485.
• Proficiency with electronic document management systems (EDMS) and quality management software.
• Strong organizational, analytical, and communication skills.
• Position is located in Alpharetta, GA and follows the hybrid schedule of being in office Tuesday, Wednesday, and Thursday.

Preferred

• Experience with EDMS platforms such as ETQ, MasterControl, Veeva Vault QualityDocs, or similar systems.
• ASQ certification (CQA, CQM) or equivalent professional certification.
• Experience supporting FDA inspections, ISO audits, or other regulatory inspections.
• Project management certification (PMP)
• Understanding of change control processes and document lifecycle management.
• Familiarity with data integrity principles (ALCOA+).

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

Join us at Avanos

Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count

Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits.

Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting.

Avanos also offers the following:

benefits on day 1

free onsite gym

onsite cafeteria

HQ region voted 'best place to live' by USA Today

uncapped sales commissions