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).
- Planshipping 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
