Auditor QA

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

Job Summary

This role must be located in the Chicagoland area. Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites.

Major Responsibilities

• Plan, schedule, and execute complex supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO 13485, MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories, and raw material suppliers.
• Evaluate Medline suppliers to determine approval status and assist in the development of Regulatory/Quality Management Systems for potential suppliers.
• Manage and participate in quality initiatives to maintain and improve compliance, such as evaluating internal processes, suggesting and implementing improvements, and creating and revising applicable procedures and SOPs.
• Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel products and services. Plan, schedule, and execute internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements.
• Conduct adequate CAPA follow‑up for supplier and internal audits.
• Write audit reports and communicate results to upper management.
• Provide training and consulting services to internal departments to comply with Quality Management System requirements.
• Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies.
• Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers.
• Plan and coordinate travel for supplier and internal audits, both domestically and internationally.

Education

• Bachelor’s degree in microbiology, chemistry, engineering or related field.

Work Experience

• At least 2 years of experience auditing FDA regulated medical device or pharmaceutical manufacturing or testing, or at least 3 years working in a quality role within medical device or pharmaceutical manufacturing.

Knowledge / Skills / Abilities

• Detail‑oriented, with excellent oral and written communication skills.
• Ability to listen and process all relevant details, understand and prioritize their importance, and draw clear and concise conclusions.
• Experience developing ways of accomplishing goals with little or no supervision, determining when escalation of issues is necessary.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

Preferred Qualifications

• Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).
• Experience with ISO 13485.
• Experience applying knowledge of process validation, method validation and sterilization processes.
• Experience in CAPA (Corrective and Preventive Actions) management.

Salary Range

$79,000.00 – $119,000.00 Annual. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Benefits

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Equal Opportunity Statement

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.