Product Quality Engineer 2

Job description

Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation. Knowledge: Skills: Behaviors: Experience: - Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP. - Familiarity with root cause analysis tools, risk management principles, and compliance frameworks. - Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterili...