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Senior Quality Assurance Auditor

1 month ago

Northfield, Minnesota, United States Medline Full time
Job Summary

Medline is seeking a highly skilled Senior Quality Assurance Auditor to join our team. As a key member of our quality assurance team, you will be responsible for auditing a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements.

Key responsibilities include:

  • Leading complex, critical, supplier regulatory projects involving cross-functional teams
  • Performing internal audits of Medline divisions and manufacturing sites
  • Developing and implementing quality management systems to ensure compliance with regulatory requirements
  • Providing training and consulting services to internal departments on quality management system requirements
  • Planning, scheduling, and executing complex and high-risk supplier audits to evaluate QMS and regulatory compliance
  • Evaluating Medline suppliers to determine approval status
  • Assisting in the development of regulatory/quality management systems for potential suppliers
  • Conducting adequate CAPA follow-up for supplier and internal audits
  • Writing audit reports and communicating results to upper management
  • Managing and participating in quality initiatives to maintain and improve compliance

Requirements:

  • Bachelor's degree in microbiology, chemistry, engineering, or related field
  • At least 4 years of experience auditing FDA regulated medical devices or pharmaceuticals, or at least 5 years working in a senior level quality role within medical device or pharmaceutical manufacturing
  • Experience with FDA regulations (21 CFR 820, 21 CFR 210/211) and ISO 13485
  • Ability to travel up to 50% of the time for business purposes

Preferred qualifications include experience with USP 61/62 for Microbial Testing of Non-Steriles, process validation, method validation, and sterilization processes, as well as CAPA management.

Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. We are an equal opportunity employer and evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.