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Process Validation Engineer (Mfg)

Company Name:
ALKU
Summary:
Our client is in need of quality engineer/process validation engineer to help out with one of their contract manufacturers. They will be helping out on the medical device side.

Essential Duties and Responsibilities:
The consultant will be a quality engineer/process validation engineer. This person will come from a manufacturing background and have a firm grasp on quality regulations as they relate to validation. This person will be working closely with the manufacturing engineering manager. Ideally, this person will come with a six sigma background. It would be a huge plus if this person has injection molding and ultrasonic welding experience. The most important aspect to this position is the ability to write ironclad validation protocols and reports in a medical device environment. They must be familiar with the 2011 guidance from FDA in process validation.

Required:
-Quality Engineering (Process Validation)
-Medical Device
-Manufacturing Background
-Contract Manufacturers
-Writing/Executing Validation Protocols




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