SENIOR STAFF AUDITOR, QUALITY SYSTEMS (ON-SITE)

Abbott Laboratories • Plymouth, MN

404d • $83,000 - $166,000

About The Position

The Senior Staff Auditor, Quality Systems at Abbott is a leadership role focused on implementing internal audits to ensure compliance with global regulatory standards. This position involves collaboration with Abbott Medical Device Business Units to prepare for FDA inspections and support audit readiness. The role includes mentoring and training auditors, managing audit schedules, and providing oversight for external inspections related to Abbott's Quality System.

Requirements

• Bachelor's degree in a related field or equivalent combination of education and experience.
• Minimum 6 years of related work experience.
• Prior experience in the medical device industry and/or quality systems.
• Strong knowledge of FDA Code of Federal Regulations applicable to medical device manufacturing, including cGMP and ISO14971.
• Proven project management skills from initiation to completion.
• Strong technical writing and communication skills.

Nice To Haves

• Demonstrated leadership and management skills in achieving company goals.
• Ability to set goals and provide constructive feedback to build relationships.
• Experience in a cross-division business unit model.
• Prior audit and management experience in Medical Devices.
• Experience in preparing for and managing external inspections, preferably with FDA.

Responsibilities

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

Benefits

• Career development opportunities within an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan after one year.
• Excellent retirement savings plan with high employer contributions.
• Tuition reimbursement and student debt programs.
• Recognition as a great place to work and for diversity.

What This Job Offers

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