JT320 - QUALITY ENGINEER II

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