Quality Engineer II role at Quality Consulting Group, working in a world-class manufacturing industry in Puerto Rico & USA, with a highly enthusiastic team.
Requirements
- Perform and/or review process validation and equipment qualification
- Experience in production line
- Basic knowledge in defining validation strategies
- Experience with Risk Management documentation: pFMEAs
- Basic knowledge in statistics (preferably using Minitab)
- Experience with projects: design requirements validation, manufacturing controls
- Knowledge in Medical Devices regulations
- Experience in GMP documentation
- Experience investigating manufacturing operations events in support to product disposition
- Experience assessing and tracing manufacturing defects/rejects trends
- Experience working and executing Design transfer activities
Benefits
- Equal opportunity employer