Hologic is seeking a Sr. Product Quality Engineer to ensure the safety, reliability, and compliance of our diagnostic and imaging solutions that advance women's health. In this role, you will lead quality engineering for new and existing products, driving robust design controls, risk management, and data-driven continuous improvement. You will collaborate closely with R D, manufacturing, and regulatory teams to investigate issues, implement effective CAPAs, and optimize test methods and inspection plans. Leveraging

ISO 13485, FDA

QSR, and statistical tools, you will analyze trends, reduce defects, and support audits while mentoring peers. At Hologic, you'll join a mission-driven, innovative culture with opportunities to grow your expertise and impact patient outcomes globally. Responsibilities Lead product quality engineering activities for diagnostic and imaging products in the biotechnology and pharmaceutical space Develop, validate, and improve quality processes, test methods, and inspection plans to meet regulatory and internal standards Investigate nonconformances and customer complaints, driving robust root cause analysis and corrective and preventive actions (CAPA) Partner with R D, manufacturing, and regulatory teams to ensure design control, risk management, and product reliability Analyze quality data and metrics to identify trends, reduce defects, and improve yield and product performance Support audits, regulatory inspections, and compliance with

FDA, ISO

13485, and other applicable standards Author and maintain technical documentation, protocols, reports, and procedures for quality activities Provide quality engineering guidance and mentoring to cross-functional and junior team members Required Skills Design of Experiments (DOE) Statistical process control (SPC) and data analysis Root cause analysis (5 Why, Fishbone, FMEA) CAPA management ISO 13485 and FDA QSR compliance Risk management and FMEA (including

ISO 14971

) Test method development and validation Reliability and verification/validation testing Technical documentation and protocol/report writing Use of quality tools (Minitab or similar)