CAPA Quality Engineer - Medical Devices

Hologic is seeking a CAPA Facilitator, Engineer to lead robust Corrective and Preventive Action (CAPA) activities that support our mission of improving women’s health. In this role, you will own cross-functional CAPA investigations, perform detailed root cause analyses, and drive effective corrective and preventive actions for medical devices and diagnostic products. You will ensure CAPA records meet FDA and ISO 13485 requirements, prepare metrics and reports, and support internal and external audits. Partnering closely with engineering, manufacturing, quality, and regulatory teams, you will standardize CAPA processes, train stakeholders in problem-solving tools, and lead continuous improvement initiatives that enhance product quality, patient safety, and compliance in a collaborative, innovation-driven environment.