Quality Assurance Auditor

Job Summary

JOB SUMMARY: 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.

Job Description

MAJOR RESPONSIBILITIES:

• 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 (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. 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, 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 pharmaceuticals manufacturing or testing OR at least 3 years working in 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, understanding and prioritizing their importance and drawing clear and concise conclusions.
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
• Experience …