Senior Quality Assurance Engineer
Senior Quality Assurance Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 BioTek.
- 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:
- Masters 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 Biotek Inc. 400 Pinnacle Way Ste 450 Norcross GA 30071. ATTN: SRGA2024
Required Experience:
Manager
Employment Type
Full-Time
