[Hiring] Auditor QA @Medline Industries, LP

Role Description

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.

• Plan, schedule and execute complex supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR, and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio.
• Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers.
• Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs.
• Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments.
• 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.

Qualifications

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

Requirements

• At least 2 years of experience auditing FDA regulated medical device or pharmaceuticals manufacturing or testing OR at least 3 years working in quality role within medical device or pharmaceutical manufacturing.
• Detail-oriented, with excellent oral and written communication skills.
• Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
• Experience developing ways of accomplishing goals with little or no supervision.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Position requires travel up to 50% of the time for business purposes.

Benefits

• Competitive total rewards package.
• Continuing education & training.
• Tremendous potential with a growing worldwide organization.
• 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 and access to the Employee Assistance Program.