Bachelor’s degree in Engineering (mechanical preferred) and minimum 5 years’ experience working in the medical or aerospace manufacturing industries. Ensure compliance to ISO9001, ISO13485, AS9100 and FDA CFR820. Responsible for the development of part specific quality plans based on customer requirements in a manufacturing environment. Experience in geometric tolerances, ability to read blueprints and interpret to ANSI specifications. Must have a good understanding and ability to develop and document Risk Assessment, FMEA and Process Control Plans, CAPA activities. Candidate must have excellent communication, organizational and computer skills. CQE, CQA, or Green Belt a plus.