Quality Engineer

Descripción del Empleo:
The QA Engineer must have experience within the Pharmaceutical and Medical Devices manufacturing environments.
Requisitos:
Minimum Requirements: Bachelor Degree in an Engineering Field (preferably Industrial, Mechanical or Electrical).
3+ years of knowledge and experience in cGMP in a Pharmaceutical or Medical Devices manufacturing environment.
3+ years of qualification / validation protocols (IQ, OQ, PQ) development, execution and auditing for a remediation plan project.
Proven Knowledge in pFMEA design and analysis, CAPA investigations and analysis
Knowledge on statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).
Project management skills required.
Fully bilingual (English and Spanish).