Biocompatabilitiy and Toxicology Scientist

Role & responsibilities:

• Solid fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology.
• Standards and Regulations Knowledge / Capability - Ability to interpret current Bio/Tox standards, understands impact of external Bio/Tox standards requirements to internal Bio/Tox processes and procedures.
• Project Knowledge / Capability - Capability (with minimal guidance / support) to provide Bio/Tox related change control & NPC/SPRING project support as well as support / provide guidance to lower-level associates.
• Product Knowledge / Capability - Advanced knowledge related to product portfolio.
• Audit / Supplier Approval & Maintenance Knowledge / Capability - Capability (via audit support experience) to support Bio/Tox lab related supplier re-evaluations & qualifications. Additionally Capability to support external audits (e.g. NSAI, FDA) with guidance.
• Complaint Management Knowledge / Capability - Capability to provide Bio/Tox support (with minimal guidance) to the complaint management process (including Bio/Tox related investigation support).
• Problem Solving Knowledge / Capability - Capability (without guidance) to support problem solving and root cause investigations for Bio/Tox laboratory test failures.
• Demonstrates fundamental understanding on biocompatibility series; ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, and biocompatibility assessment methodology.
• Knowledge in Quality Systems standards and FDA Medical Device Regulations (i.e., ISO 13485; QSR).