Medline Industries is seeking an Associate Sterility Assurance Specialist in Redmond, OR, to prepare and execute sterilization activities for medical devices and pharmaceuticals, ensuring compliance with FDA and ISO standards. The ideal candidate will have a background in life sciences or engineering, relevant experience in an FDA-regulated environment, and the ability to manage sterilization processes and documentation
Job Summary
The role involves preparing and executing sterilization activities to ensure compliance with FDA regulations and ISO standards.
Candidates will be responsible for reviewing test results, analyzing environmental data, and assigning sterilization cycles to new products.
Medline offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off.
Matching Summary
Match Score: 85
Medline Industries is seeking an Associate Sterility Assurance Specialist in Redmond, OR, to prepare and execute sterilization activities for medical devices and pharmaceuticals, ensuring compliance with FDA and ISO standards. The ideal candidate will have a background in life sciences or engineering, relevant experience in an FDA-regulated environment, and the ability to manage sterilization processes and documentation.
Salary
Base: $67,000.00 - $101,000.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life and disability, 401(k), PTO
Skills & Requirements
Must-have
FDA regulated industry experience
ISO 11135 sterilization standards
Bioburden and residual testing
Validation protocol preparation
Temperature and humidity data analysis
Nice-to-have
Contract vendor training experience
Process deviation resolution skills
Cross-functional collaboration abilities
Key Requirements
Bachelor's Degree in life sciences or engineering
2-4 years of work experience in sterilization
At least 1 year relevant experience in an FDA regulated industry