Quality Engineer 2

Are you passionate about ensuring the highest quality standards for life-saving medical devices? At Hologic, we are seeking a Quality Engineer II to drive compliance, risk management, and continuous improvement across our product lifecycle. In this role, you'll collaborate with cross-functional teams to lead investigations, implement corrective actions, and support design transfers while leveraging your expertise in regulatory compliance and quality systems. If you're a proactive problem-solver with a strong commitment to operational excellence and customer satisfaction, this is your opportunity to make a meaningful impact on healthcare innovation.

Knowledge:

• In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality.
• Strong understanding of risk management principles, including ISO 14971 and PFMEA, to support design