Must have 4 years of experience in the position offered or a related position; Must have 4 years of experience with FDA regulated medical device industry regulations with regards to Quality control procedures and systems, such as Engineering Change Management System, Nonconformance Report and Disposition, Engineering Specifications, Corrective and Preventive Action CAPA, and Work Instructions; Must have 4 years of experience executing equipment qualification and process validation projects; Must have 4 years of experience developing and executing project plans and task scheduling; Must have 4 years of experience with statistical process control concepts, process development; Must have 3 years of experience with problem solving with root cause analysis utilizing process capability studies and six sigma in a manufacturing environment; Must have 3 years of experience conducting feasibility studies to estimate product cost as well as analyze capital equipment, capacity, and capability requirements; Must have 1 year of experience developing timelines and leading largescale expansion projects; Must have 1 year of experience with diffusion bonding process utilizing furnaces. problem solving with root cause analysis utilizing process capability studies and six sigma in a manufacturing environment; Must have 3 years of experience conducting feasibility studies to estimate product cost as well as analyze capital equipment, capacity, and capability requirements; Must have 3 years of experience executing equipment qualification and process validation projects; Must have 3 years of experience developing and executing project plans and task scheduling; and Must have 3 years of experience with Statistical Process Control concepts, process development, geometric dimensioning tolerancing, CNC programming terminology, and tooling design concepts.
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