Quality Auditor - Medical Devices and Pharmaceuticals - Remote

Overview

This role is primarily responsible for auditing sterilization processes to ensure compliance with regulatory standards and internal quality requirements.

In Short

• Audit a broad, global supplier base against FDA regulations and ISO standards.
• Perform internal audits of Medline divisions and manufacturing sites.
• Lead complex supplier regulatory projects involving cross-functional teams.
• Travel up to 50% of the time for business purposes.

Requirements

• Bachelor’s degree in microbiology, chemistry, engineering or related field.
• 4+ years of experience auditing FDA regulated medical devices or pharmaceuticals.
• Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).
• Experience with ISO 13485.
• Detail-oriented with excellent communication skills.

Benefits

• Competitive total rewards package.
• Continuing education & training.
• Health insurance, life and disability, 401(k) contributions.
• Tremendous potential with a growing worldwide organization.