Quality Design Engineer 2

As a key member of the Quality Engineering team, 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 will work with product development teams to ensure that appropriate design control measures are applied during the development and transfer of Hologic products.

Requirements

• Work effectively and influence multiple functions to ensure teams understand and implement appropriate regulations for all areas of design controls.
• Provide Quality Engineering support for product design and development from feasibility through transfer into commercialization.
• Support Research and Development teams with platform or systems reliability testing and characterization with both hardware and software.
• Serve as Core team member on New Product Development projects to ensure compliance with design controls per ISO 13485 and FDA QSR.
• Lead or support non-conformance or CAPA related initiatives.
• Review and support compliance studies to ensure device electrical safety is maximized mitigated through standardized approach in conforming to IEC 60601.

Benefits

• Comprehensive training when you join, as well as continued development and training throughout your career.