We are seeking an experienced Quality Engineering professional in the medical device manufacturing industry to serve as Project Lead for the development and harmonization of an endotoxin testing strategy across three manufacturing sites. This role will lead and execute risk-based technical assessments in compliance with AAMI ST72 and USP <85>, author key technical documentation, and coordinate cross-functional implementation activities including laboratory, manufacturing, quality systems, and ERP (SAP) updates.

Key Responsibilities

• Lead the development of risk-based endotoxin testing strategies in accordance with AAMI ST72 and USP <85>.


• Author high-quality technical documentation, including:


• Technical risk assessments


• Scientific justifications


• Protocols, reports, and implementation plans


• Apply biological and microbiological principles (e.g., microorganisms, material properties, envir...