Quality Engineer 2 - Post Market Surveillance and Investigation

Job description

This Quality Engineer role monitors the quality and safety of Hologic’s on-market molecular diagnostic products. This role will build and sustain processes and tools to monitor product performance, monitor product risk, trend complaint / field data, and support risk assessment of on-market issues / trends. This role additionally applies technical expertise with in vitro diagnostic reagents / systems, data analysis, and root cause analysis methods to address product issues as well as support continuous improvement across Hologic’s global molecular diagnostic product lines. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. - Work hands-on to implement state-of-the-art complaint and adverse event trending metrics and methods, including definition / optimization of complaint trending codes, analysis methods, and trending action limits - Sustain routine monitoring and trending of product performance, complaint data, adverse event reporting data, and quality KPI’s to identify and track potential product issues - Create, sustain, and an...