Quality Design Engineer 2

Job description

As a key member of the Quality Engineering team at Hologic, the Design Quality Engineer plays an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. The successful candidate will work with product development teams to ensure that appropriate design control measures are applied during the development and transfer of Hologic products. The individual will apply “systems” thinking and knowledge of medical device products, molecular diagnostics, regulatory standards or applicable industry, design verification and validation, manufacturing transfer, test method development principles, and risk management to support new and sustaining projects. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. Work effectively and influence multiple functions (R&D, Software & Hardware Engineerin...