Sterility Assurance Quality Engineer III

Owens & Minor

Alpharetta (GA)

On-site

USD 100,000 - 120,000

Full time

7 days ago
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Benefits offered by this job

Educational Assistance
Employer-Paid Life Insurance and Dis­a

Job summary

Owens & Minor is a global healthcare solutions company with 140+ years of service and 14,000 teammates. The Quality Engineer III, Sterility Assurance and Environmental Controls, provides specialized expertise in terminal sterilization and related validation activities supporting medical products and manufacturing operations.

The role independently executes complex technical work, supports investigations, and partners across functions to ensure sterilization processes meet regulatory and quality

Qualifications

  • Bachelor’s degree and 5+ years in terminal sterilization or related Quality Engineering.
  • Experience developing and executing sterilization validation for medical products.
  • Experience auditing contract sterilizers, laboratories, and suppliers.
  • Experience with Ethylene Oxide, Gamma irradiation, or Electron-Beam sterilization.

Responsibilities

  • Provide technical expertise in terminal sterilization, sterility assurance, environmental controls.
  • Develop, coordinate, and execute sterilization validation/qualification activities.
  • Evaluate changes to products, materials, and processes for sterilization impact.
  • Prepare validation plans, reports, and technical documentation.
  • Coordinate qualifications for contract sterilizers and external labs.
  • Support investigations of sterilization failures and CAPAs.

Skills

Sterilization
Sterility Assurance
Quality Engineering
Root-Cause Analysis
Validation
Microbiology
Regulatory Compliance

Education

Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality

Job description

Owens & Minor is a global healthcare solutions company with 140+ years of service and 14,000 teammates. The Quality Engineer III, Sterility Assurance and Environmental Controls, provides specialized expertise in terminal sterilization and related validation activities supporting medical products and manufacturing operations.

The role independently executes complex technical work, supports investigations, and partners across functions to ensure sterilization processes meet regulatory and quality

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