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QA Auditor I

QUA0100QGNorthfield, Illinois

Job Description

Medline Industries has an immediate opening for a Quality Auditor I position, located in Northfield, IL headquarters. The Quality Auditor l will be responsible for under direct supervision auditing global supplier base against FDA regulations for medical devices, pharmaceuticals, biologics and applicable ISO standards. 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: 
  • Execute supplier audits in accordance with FDA regulations and ISO standards for medical device, pharmaceuticals, cosmetics, dietary supplements, medical food and biologics.
  • 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 present to senior staff for review.

Job Qualifications

  • Bachelor’s Degree.
Relevant Work Experience
  • At least 1 year of experience auditing FDA regulated Medical Device or Pharmaceutical manufacturing and testing.
  • 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 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 controlling and coordinating concurrent projects, competing priorities and critical deadlines.
  • Bachelor’s degree in microbiology, chemistry, engineering or related field.
Relevant Work Experience
  • Experience wih FDA QSR Quality System Regulation and/or FDA 210, 211.
  • Experience with USP 61/62 for Microbial Testing of Non-Steriles.
  • Experience in CAPA (Corrective and Preventive Actions) management