HOLOGIC, INC. – $120,952.00/Year

Requires a Bachelors degree in Industrial Engineering or related field plus four years of quality engineering experience. Four years of experience must include four years of experience with each of the following 1 FDA Quality System Regulation, ISO 13485, and the Medical Device Directive; 2 ISO 14971, experience in risk evaluation techniques including FMEA, fault tree analysis or HACCP Hazard Analysis and Critical Control Points; 3 statistical methods and design of experiments; 4 APQP, PPAP including Applicable Part and Process Qualification Methodology; and 5 utilizing standard root cause analysis tools.