Katie Bell Email & Phone Number

• Collaborate with associates of diverse technical backgrounds and partner with project team engineers, quality engineering, manufacturing, packaging, sterilization, and regulatory Subject Matter Experts to achieve.
• Compile/write biocompatibility strategies, evaluations, and process approval memos
• Act as study sponsor for testing conducted at external testing laboratories, especially NVR/FTIR, ICP/MS, and cytotoxicity testing
• Ensure all testing meets ISO, FDA, CDRH, and GLP requirements
• Review engineering protocols and external lab protocols and reports for completeness and accuracy
• Assess and document test results, primarily for NVR/FTIR, ICP/MS, and cytotoxicity testing

• Review memos for biocompatibility strategies, material approvals, and device approvals; Compile data from testing or other evaluation/approval documentation for company databases and archives
• Review device bill of materials, engineering drawings, and supplier documentation for accuracy and transcription to new documents, for material and manufacturing process information and identification of potential.
• Prepare biocompatibility samples to be sent for testing by providing guidance on sample collection, handling, packaging, and inspection
• Orchestrate testing of biocompatibility samples with contract laboratories, determine sample requirements, and review and provide feedback on engineering studies
• Verify accuracy of test-sample information on analytical test reports and the presentation of the data; verify risk assessment calculations for Toxicologists
• Maintain and track biocompatibility test samples through progression of testing and to final off-site storage and create and manage documentation for vital records

Cincinnati, OH

Cincinnati, Ohio

Cincinnati, OH

Cincinnati, OH

Cincinnati, OH

Paleoethnobotanical Research

West Chester, OH