Senior Sterility Assurance Engineer

Owens & Minor Distribution Inc.; Atlanta (GA); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Educational Assistance

Employer-Paid Life Insurance

Disability Coverage

HSA and 401(k)

Parental leave

Paid Leave

Well-Being programs

Adoption assistance

Job summary

Owens & Minor is seeking a Quality Engineer III to provide specialized expertise in terminal sterilization, sterility assurance, and environmental controls for medical products. You will independently execute complex technical work, support investigations, and partner across functions to ensure compliant sterilization processes.

The role includes developing validation plans for EO, gamma, and electron-beam sterilization, coordinating supplier qualifications, and guiding change controls within a

Qualifications

• Bachelor’s degree in Microbiology, Engineering, Biological Sciences, Quality, or related field.
• 5+ years in terminal sterilization, sterility assurance, microbiology, quality engineering, or validation.
• Experience developing sterilization validation for medical products.
• Experience with EO, gamma, and E-beam sterilization.
• Audits/assessments of contract sterilizers or labs.
• Independent work and ability to lead defined projects.

Responsibilities

• Provide technical expertise in terminal sterilization and sterility assurance.
• Develop and execute sterilization validation plans and protocols.
• Support product and process changes affecting sterilization requirements.
• Coordinate qualification activities for contract sterilizers and facilities.
• Ensure compliance with quality systems and regulatory expectations.
• Lead investigations and root-cause analyses for sterility issues.

Skills

Sterilization

Sterility assurance

Environmental controls

Quality engineering

Root-cause analysis

Analytical skills

Education

Bachelor's degree in Microbiology, Engineering, Biological Sciences or Quality

Tools

EO sterilization

Gamma irradiation

Electron-beam irradiation

Job description

Owens & Minor is seeking a Quality Engineer III to provide specialized expertise in terminal sterilization, sterility assurance, and environmental controls for medical products. You will independently execute complex technical work, support investigations, and partner across functions to ensure compliant sterilization processes.

The role includes developing validation plans for EO, gamma, and electron-beam sterilization, coordinating supplier qualifications, and guiding change controls within a