Senior Quality Assurance Engineer
Job Title: Senior Quality Assurance Engineer
- Research and develop Validation Protocols and Reports including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
- Plan s hipping Study protocols and reports for Products and medical devices including Magbinder Fit 24.
- Improving Labeling Process and Labeling imperfections.
- Participate and Perform Internal Audits, Customer Audits.
- Design Process FMEA for Magbinder Fit24 device.
- Support Product Development Process including development of Design Inputs, outputs, design transfer.
- Design multiple study protocols and reports for manufacturing equipment utilized at Omega Bio-Tek .
- Use equipment including Hamilton Star , Tecan Liquid Handler , Filling and Capping Machines , and Environmental Chambers .
- Utilize skills of Ensur, ANSI, PLEX ERP, Minitab, AutoCAD
- Master’s Degree in industrial engineering, Industrial and Systems Engineering , or closely related field,
- Two year s of experience as Validation Engineer in the execution of Operational and Process Qualification (OQ, PQ) in collaboration of Operations, Manufacturing and R&D .
- Two years of experience in authoring Installation Qualification (IQ) Operational Qualification (OQ) , and Performance Qualification (PQ)
- Skills in SolidWorks, AutoCAD, MATLAB, Minitab, and Lean Manufacturing
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