Hologic
Newark, DE, USA
Job Description Are you passionate about driving quality improvements and ensuring the safety and reliability of life-changing medical devices? At Hologic, we are seeking a Quality Design Engineer II to lead design changes, product enhancements, and quality projects while ensuring compliance with regulatory standards. In this role, you'll collaborate across departments to analyze post-market data, conduct root cause investigations, and develop solutions that enhance product performance and customer satisfaction. If you're a detail-oriented problem solver with expertise in design verification, validation, and regulatory compliance, we encourage you to apply and make an impact on healthcare innovation. Knowledge: Expertise in FDA Quality Systems Regulation (QSR), Design Control requirements, ISO 13485, ISO 14971 (Risk Management), and Medical Devices Directive. Strong understanding of manufacturing processes, including machining, injection molding, common joining methods,...
