Senior Quality Engineer

Position Overview:

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...