HOLOGIC, INC. – $108,181.00/Year

Requires a Bachelors Degree in Engineering Biomedical, Industrial, Mechanical, or Aerospace, or related field plus five years of quality engineering experience in the medical device quality assurance industry. The five years of experience must include two years of experience with each of the following 1 working in a product development or Research Development environment; 2 FDA Quality System Regulations including Design Control requirements, ISO 13485, and Medical Device Directive; 3 ISO 14971 Risk Management; 4 working with usability, reliability, electrical safety, software, sterilization, packaging and biocompatibility standards and requirements; 5 leading quality related activities for NPD and sustaining projects; 6 regulatory audits; and 7 quality tools and statistical programs including Minitab, risk assessment FMEA, FTA, experimental design DOE and process improvement SPC.br Up to 20 domestic travel to other Hologic sites.