STAFF AUDITOR, QUALITY SYSTEMS MANAGER (ON-SITE)

Abbott Laboratories • Green Oaks, IL

415d

About The Position

The Staff Auditor, Quality Systems Manager is a leadership role responsible for implementing internal audits to ensure compliance with global regulatory standards. This position involves collaboration with Abbott Medical Device Business Units to prepare for and support FDA inspections. The role requires strong leadership and mentoring skills to enhance the audit and inspection readiness program.

Requirements

• Bachelor's degree in a technical field (Science or Engineering) or equivalent combination of education and experience.
• Minimum 8 years' experience in the medical device/pharmaceutical industry.
• Minimum 5 years' experience in Quality Assurance, Internal Auditing, Quality Compliance Management, or related experience.

Nice To Haves

• Demonstrated leadership/management skills in achieving company goals and objectives.
• Strong leadership skills with the ability to set goals and provide constructive feedback.
• Experience in a broader enterprise/cross-division business unit model.
• Prior audit and management experience in Medical Devices.
• Experience in preparation and management of external inspections, preferably with FDA.

Responsibilities

• Plan and develop internal global Abbott affiliate audit schedules and plans.
• Perform and document audits, managing related follow-up activities including KPI and metrics reporting.
• Support the development, training, and supervision of auditors to enhance their inspection readiness capabilities.
• Lead and mentor staff, influencing colleagues and peers to improve the audit and inspection readiness program.
• Provide leadership and project management for external inspections related to Abbott's Quality System.

Benefits

• Career development opportunities within a global company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan after qualifying.
• Excellent retirement savings plan with high employer contributions.
• Tuition reimbursement and education benefits for pursuing a bachelor's degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees