Sr Engineer Sterilization

Job Description

General Objective

Provide quality assurance and technical sterilization support to the terminal sterilization of medical devices and other healthcare products. The position will support the
Medline Product Divisions and external customers in order to maintain compliance to regulations and industry standards including 21 CFR Part 820, ISO11135 and ISO13485.
Ensure product processing, regulatory requirements, and equipment requirements are met in accordance with specifications including calibrations, internal, customer and regulatory audits, validations, record keeping and reporting.

Responsabilities

• Monitor trending and data relative to quality system and make recommendations for improvement as well as establish implementation plans. Prepare reports for monthly, quarterly, and semi-annual trending and host monthly Quality Review Board meetings with Management.
• Perform or facilitate the review and mainten...