Documentation Services Manager – EDM & Compliance Leader

Abbott (abbottcareers2 board); Lake Forest (IL); On-site; USD 105,000 - 150,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

Excellent retirement savings plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Manager Documentation Services in Lake Forest, IL, to lead the documentation team within the Core Lab of Diagnostics. The role focuses on governing document control, change management, and technical publications under FDA, GMP, ISO standards while implementing EDM programs.

You will partner with Quality, Manufacturing, Development, and Legal to drive compliant documentation practices and operational excellence across manufacturing and product development.

Qualifications

• Bachelor's degree in Engineering, Science, or a related field or equivalent experience.
• Minimum 10 years in documentation management with experience in NPI, drafting and electronic data management.
• Strong leadership skills required for this management role.

Responsibilities

• Oversee daily department activities, set priorities, schedules, and drive continuous process improvement.
• Define resources and budgets to meet project schedules; monitor performance and status.
• Ensure compliance with ISO and 21CFR 820 Quality System Regulation.
• Coordinate documentation change control across facilities globally.
• Maintain Device Master Record and provide audit-ready documentation history.

Skills

Leadership

Delegation

Resource planning

Problem solving

Team building

Customer service

Budget management

Education

Bachelor's degree in Engineering/Science or related field

Tools

EDM program

Job description

Abbott is seeking a Manager Documentation Services in Lake Forest, IL, to lead the documentation team within the Core Lab of Diagnostics. The role focuses on governing document control, change management, and technical publications under FDA, GMP, ISO standards while implementing EDM programs.

You will partner with Quality, Manufacturing, Development, and Legal to drive compliant documentation practices and operational excellence across manufacturing and product development.