Senior Microbiologist (remote)

Orthopedicjobs

Fully remote
Sterility assurance activities
Microbiology and sterilization documentation review
Eto and radiation sterilization validation
As Senior Microbiologist, you will be responsible for ensuring sterility compliance of medical devices in accordance with applicable regulatory standards

Job Summary

  • As Senior Microbiologist, you will be responsible for ensuring sterility compliance of medical devices in accordance with applicable regulatory standards.
  • You will support the validation, monitoring, and continuous improvement of cleaning and sterilization processes, collaborating cross-functionally to ensure product quality and regulatory compliance in a global, regulated environment.
  • Act as a subject matter expert in microbiology and sterilization for Finished Goods, supporting regulatory compliance and internal procedures.

Matching Summary

As Senior Microbiologist, you will be responsible for ensuring sterility compliance of medical devices in accordance with applicable regulatory standards.

Skills & Requirements

Must-have

  • Sterility assurance activities
  • Microbiology and sterilization documentation review
  • EtO and radiation sterilization validation
  • Microbiological and process data analysis
  • Nonconformance investigations and CAPA

Nice-to-have

  • Supplier quality support
  • External sterilization process support
  • Regulatory agency interaction

Key Requirements

  • Bachelor’s degree in Microbiology
  • Minimum 3 years of experience
  • Experience reviewing technical documentation
  • Knowledge of ISO 11135, ISO 11137, ISO 14644
  • Fluent English proficiency
  • Proficiency in Microsoft Office

Work Rights

Not specified

Tailored Resume

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