Senior Quality Assurance Engineer

Norcross, GA

Full Time

Mid Level

Job Title: Senior Quality Assurance Engineer

Job Location: Norcross, GA

Job Duties:

Research and develop Validation Protocols and Reports including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Plan shipping 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

Requirements:

Master’s Degree in industrial engineering, Industrial and Systems Engineering, or closely related field,
Two years 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

To apply: Mail resume to HR, Omega Bio-tek, Inc. 400 Pinnacle Way, Ste 450, Norcross, GA 30071. ATTN: SRGA2024

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