Medical device manufacturer in the greater Knoxville, TN area is growing! Immediate need for a Quality Engineer to support Validations for new product introductions. The Quality Engineer will work with Process Validations and Equipment Qualifications in a GMP environment. The QE will work with Root Cause Analysis (RCA) and Corrective Actions Preventative Actions (CAPA) as well as 5 Whys, FMEA, fishbone, 8D control planning, etc.
Qualified candidates will have BS Engineering degree along with at least 3 years experience in an FDA-regulated environment working with 21 CFR regulations and ISO-13485.
Excellent company that has been growing rapidly through acquisitions and new product development. The corporation operates multiple manufacturing facilities in the United States.
Relocation assistance is available.