Bachelor s degree in Engineering and minimum 5 years experience as a quality manager in the medical manufacturing industries. Ensure compliance to ISO9001, ISO13485, and AS9100. 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. Responsible for managing a staff of Quality Engineers and Mechanical Inspectors.