Medline Industries, Inc.
Description Medline Industries has an immediate opening for a Quality Auditor II position, located in Northfield, IL headquarters. The Quality Auditor ll will be responsible for under direct supervision auditing a\u00a0broad supplier base against FDA regulations for medical devices, pharmaceuticals, biologics and applicable ISO standards. Additionally, the Quality Auditor will play an integral role in Medline\u2019s internal audit program, working with the audit team to audit all Medline Divisions and manufacturing plants globally. We are seeking a dynamic, hardworking professional with a solid education, leadership potential and background in quality along with a desire to work for a fast-paced, large corporate organization. Also you must have a roll-up your sleeves attitude.\u00a0 Responsibilities include: Plan, schedule and execute supplier audits in accordance with FDA regulations and ISO standards for medical device, pharmaceuticals, cosmetics, dietary supplements, medical food and biologics. Plan, schedule and execute internal audits in accordance with applicable FDA regulations and ISO standards. Conduct adequate CAPA follow-up for supplier and internal audits. Write audit reports and communicate results to upper management. Qualifications Requirements qualifications: Bachelor\u2019s Degree. At least 3 years of experience auditing FDA regulated medical device or pharmaceuticals OR at least 3 years working in quality role within medical device or pharmaceutical manufacturing. Willing to travel up to 50% of the time for business purposes (within state, out of state and\/or internationally). Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. Preferred qualifications: Bachelor\u2019s degree in microbiology, chemistry, engineering or related field. Experience with FDA QSR Quality System Regulation and\/or FDA 210, 211. Experience applying knowledge of process validation, method validation and sterilization processes. Understanding of how to interpret microbiological methods and method validation. Experience in design controls, 510ks submissions, or CE file development. Experience in CAPA (Corrective and Preventive Actions) management.
Medline Industries, Inc.
Website : http://www.medline.com
Medline is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 350,000 products that serve the entire continuum of care. Our innovative products and programs can be found in most hospitals, extended-care facilities, surgery centers, physician offices, home care dealers, home health agencies and retail outlets.