Document Control Coordinator I: Access & Compliance

Abbott; Plymouth (MN); On-site; USD 25,000 - 49,000; Full time

Job summary

Abbott is seeking a Quality Support Specialist to provide access management for a document control system within the Electrophysiology business. You will process access requests, ensure compliance, and maintain records.

The role also involves supporting audits, collaborating with cross-functional teams, and driving process improvements to enhance efficiency and service. Prior Windchill experience and FDA/ISO knowledge are preferred.

Qualifications

• Experience with documentation control or product surveillance systems is preferred.
• Knowledge of FDA, GMP, and ISO 13485.
• Strong written and verbal communication skills.

Responsibilities

• Process documentation system access requests and ensure timely completion per procedures.
• Review requests for completeness, accuracy, approvals, and compliance requirements.
• Grant, modify, and remove user access within documentation and quality systems.
• Provide customer support and guidance regarding access-related inquiries.
• Troubleshoot and resolve documentation system access issues and incidents.
• Maintain accurate records of access management activities.
• Support audits, inspections, and periodic access reviews.
• Drive continuous improvement to enhance process efficiency and customer service.
• Collaborate with cross-functional stakeholders to ensure compliant access management processes.

Skills

Quality systems

Access management

Documentation

Communication

Education

High School Diploma/GED

Tools

Windchill

Job description

Abbott is seeking a Quality Support Specialist to provide access management for a document control system within the Electrophysiology business. You will process access requests, ensure compliance, and maintain records.

The role also involves supporting audits, collaborating with cross-functional teams, and driving process improvements to enhance efficiency and service. Prior Windchill experience and FDA/ISO knowledge are preferred.