Quality Project Manager - Sterilization

Job Summary

The Quality Project Manager – Sterilization is responsible for leading and executing sterilization-related quality initiatives across manufacturing sites. This role combines strong sterilization technical expertise (EtO, steam, gamma) with structured project management capabilities to drive standardization, compliance, continuous improvement, and quality maturity. The position supports the development and implementation of standardized sterilization processes, validation programs, and QMS improvements while ensuring compliance with FDA, ISO 13485, and applicable regulatory standards. This role works cross-functionally with Engineering, Operations, Regulatory, R&D, and Quality teams to execute projects on time, within scope, and within budget.

Essential Duties and Responsibilities