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QA Auditor II

Medline Industries, Inc. Winnetka Full-Time
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Medline Industries has an immediate expansion 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 broad 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’s 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. 
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.

Education
  • Bachelor’s Degree.
Relevant Work Experience
  • 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.
Additional
  • 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: 


Education
  • Bachelor’s degree in microbiology, chemistry, engineering or related field.
Relevant Work Experience
  • Experience with FDA QSR Quality System Regulation and/or FDA 210, 211.
  • Experience applying knowledge of process validation, method validation and sterilization processes.
  • Experience with USP 61/62 for Microbial Testing of Non-Steriles.
  • Experience in CAPA (Corrective and Preventive Actions) management.

Recommended skills

Auditing
Scheduling
Pharmaceuticals
Internal Auditing
Manufacturing
Engineering

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QA Auditor II
Estimated Salary: $73K
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Job ID: QUA0100QF

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Medline is the largest privately held manufacturer and distributor of medical supplies uniquely positioned to provide products, education and support across the continuum of care. Our ability to bring best practices from one care setting to another--- from large healthcare systems and independent physician practices to home health patients and their families, is what sets us apart.

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