Design Quality Engineer I (m­­/­­f­­/­­d)

Minimum of a Bachelor's Degree in an engineering or science field, or equivalent work experience Several years of hands-on experience; preferably in an FDA / MDR regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current good manufacturing practices, quality system regulations, and ISO standards Specific experience in medical device design controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design input Specific experience designing, preparing, executing, and statistically analyzing validations as well as developing report packages to approve equipment, processes, methods and software Goal-oriented team player with an open mind and a high level of adaptability, eager to embrace new ideas quickly Ability to work independently with minimal supervision