Responsibilities :
- Perform continuous improvements and ongoing support of existing manufacturing lines and process / product development lifecycle.
- Navigate the complexities of government and industry regulations to include ISO and cGMP (Current Good Manufacturing Practices).
- Assist in the launching of new products and processes from concept to final release in manufacturing.
- Utilize DOE (Design of Experiment), QSR (Quality Systems Regulations), and IQ / OQ / PQ (Installation Qualification, Operational Qualification, Performance Qualification).
- Understand Risk-based failure mode analysis (PFMEA and PFMECA).
- Conduct Data Analysis using SPC (Statistical Process Control) principles and Minitab.
- Coordinate small to medium scale projects, coordinating activities, resources, and project timelines.
- Utilize Lean and Six Sigma practices to include DMAIC processes and root cause analysis, S, scrap reduction and yield improvements.
- Coordinate various CAPA (Corrective Action / Preventative Action) projects. Supporting software projects to include Microsoft Project.
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