Senior Quality Engineer (Disposables)

The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA’s, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders.

Essential Job Functions and Responsibilities

Core Job

• Manufacturing process sustaining (Cleanroom environment).
• Sterilization concepts and product release.
• Contractor´s management, such as external laboratories and sterilization sites.
• Quality Inspectors management.

Supporting

• NPI’s activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ)
• Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
• Analyzes and performs failure analysis to non-conforming products.
• Le...