Quality Manufacturing Process Engineer- Healthcare

medmix•Flowery Branch, GA

15h

About The Position

As a Quality Manufacturing Process Engineer - Healthcare you will bridge the design and production to ensure efficient, high-quality manufacturing operations. Must specialize in optimizing production workflows, implementing quality management systems (ISO 9001), 13485/21 CFR 820 and 21 CFR 210/211. Experience utilizing statistical process control (SPC), conducting root cause analysis to reduce waste, defects, and ensure compliance. Focus on continuous improvement (Lean/Six Sigma) to boost productivity.

Requirements

Technical Knowledge: Proficiency in AutoCAD/SolidWorks, GD&T (Geometric Dimensioning and Tolerancing), and statistical software.
Methodologies: Strong experience with Lean manufacturing, Six Sigma, and DMAIC (Define, Measure, Analyze, Improve, Control).
Analytical Skills: Ability to interpret data, charts, and reports to drive improvements.
Education/Experience: Usually requires a bachelor’s degree in engineering (Mechanical, Industrial, Chemical) and experience in manufacturing environments.

Responsibilities

Process Optimization: Develop and refine manufacturing processes to improve efficiency, reduce costs, and minimize waste.
Quality Control & Assurance: Define quality parameters, set up monitoring systems (SPC), and develop end-of-line testing procedures.
Problem Solving: Analyze manufacturing data, identify bottlenecks, and solve issues using tools like PFMEA (Process Failure Mode and Effects Analysis), Gauge R&R, and root cause analysis.
Documentation & Compliance: Maintain, document, and audit quality management systems (e.g., ISO 9001, FDA regulations).
Supplier & Technical Support: Work with suppliers to ensure raw material quality and assist in New Product Introduction (NPI) projects.