Senior Quality Assurance Engineer

Omega Bio-tek, Inc.; Norcross (GA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in Norcross, GA is seeking a Senior Quality Assurance Engineer. The role involves developing validation protocols, improving labeling processes, and supporting product development. Candidates should have a Master’s degree and relevant experience in validation engineering. This is an exciting opportunity to contribute to innovative medical device solutions.

Qualifications

• Two years of experience as a Validation Engineer.
• Experience in authoring IQ, OQ, and PQ protocols.

Responsibilities

• Research and develop Validation Protocols and Reports.
• Participate in Internal Audits and Customer Audits.
• Design multiple study protocols for manufacturing equipment.

Skills

Validation Engineering

Lean Manufacturing

Problem Solving

Education

Master’s Degree in Industrial Engineering

Tools

SolidWorks

AutoCAD

MATLAB

Minitab

Job description

Job Title: Senior Quality Assurance Engineer

Job Location: Norcross, GA

Job Duties:

1. Research and develop Validation Protocols and Reports including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
2. Plan shipping Study protocols and reports for Products and medical devices including Magbinder Fit 24.
3. Improve Labeling Process and address Labeling imperfections.
4. Participate in and perform Internal Audits and Customer Audits.
5. Design Process FMEA for Magbinder Fit24 device.
6. Support Product Development Process including development of Design Inputs, Outputs, and Design Transfer.
7. Design multiple study protocols and reports for manufacturing equipment used at Omega Bio-Tek.
8. Operate equipment including Hamilton Star, Tecan Liquid Handler, Filling and Capping Machines, and Environmental Chambers.
9. Utilize skills in Ensur, ANSI, PLEX ERP, Minitab, AutoCAD, SolidWorks, MATLAB, and Lean Manufacturing.

Requirements:

1. Master’s Degree in Industrial Engineering, Industrial and Systems Engineering, or a closely related field.
2. Two years of experience as a Validation Engineer in executing Operational and Process Qualifications (OQ, PQ) in collaboration with Operations, Manufacturing, and R&D.
3. Two years of experience in authoring IQ, OQ, and PQ protocols and reports.
4. 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