Global Supplier QA Auditor: FDA/ISO Compliance

Medline; Illinois; On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline is seeking a Regulatory & Quality Auditor to join our team in the Chicagoland area. This role will audit a broad global supplier base for FDA, ISO 13485, MDSAP and other global regulatory requirements across Medline’s finished product portfolio, including APIs, medical devices, cosmetics, pharmaceuticals, and more.

The role requires planning and executing supplier audits, evaluating supplier approval, maintaining QMS processes, and assisting with CAPA and internal training.

Qualifications

• Detail-oriented with strong written and verbal communication.
• Experience auditing FDA-regulated medical devices or pharmaceuticals, or QA in medical devices/pharma.
• Ability to manage multiple audits, timelines and priorities.

Responsibilities

• Plan, schedule, and execute complex supplier audits to evaluate QMS and regulatory compliance.
• Evaluate suppliers for approval and assist in developing regulatory/quality systems.
• Write audit reports and communicate results to upper management.
• Provide training and consulting to internal departments on QMS requirements.
• Assist in FDA inspection preparation for Medline facilities and suppliers.

Skills

Detail oriented

Communication skills

Auditing ability

Project coordination

Travel readiness

Education

Bachelor\'s degree in microbiology, chemistry, engineering or related field

Job description

Medline is seeking a Regulatory & Quality Auditor to join our team in the Chicagoland area. This role will audit a broad global supplier base for FDA, ISO 13485, MDSAP and other global regulatory requirements across Medline’s finished product portfolio, including APIs, medical devices, cosmetics, pharmaceuticals, and more.

The role requires planning and executing supplier audits, evaluating supplier approval, maintaining QMS processes, and assisting with CAPA and internal training.