*Bachelor's of Science degree in Biology, Pharmacy, Life Sciences, Quality, Engineering or related field. Requires 5+ years of quality experience in a FDA regulated manufacturing industry (First preference is Medical Device/Pharmaceutical, but open to other regulated industries such as Defense or Food.)
*Experience with MRB process (i.e. product dispositioning) and managing CAPA's; meaning that if there is a non-conformance on a product, the QE analyzes it, makes a decision to scrap it, rework the product or accept it as is. Quality has the final word.
*Individual will have strong knowledge/backgroun in statistical analysis techiques.
*Will have experience with designing, implementing and evaluating quality assurance and/or control methods and systems.
*Must have statistical analysis/experience (Minitab preferred).