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Sterility Assurance Scientist at Integra LifeSciences - ApplyBlast

Sterility Assurance Scientist

Integra LifeSciences

3 months ago

3.1 on Glassdoor

United States

Onsite

Full Time

Senior

0 applicants

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About this role

The Sterility Assurance Scientist supports compliance with regulatory standards for sterilization, contamination control, and microbial testing across medical device manufacturing. The role collaborates with product development, packaging, regulatory affairs, operations, and quality teams to ensure technical soundness and regulatory adherence of sterilization processes.

Responsibilities

Serve as subject matter expert for sterilization
Develop and revise sterilization procedures and methodologies
Perform EU MDR gap analysis and implement resolution plans
Lead sterilization and cleaning validation projects across product families
Provide training and guidance to cross‑functional teams on contamination control and sterility requirements