Job Description:

· BS or advanced degree in technical disciplineAll potential candidates should read through the following details of this job with care before making an application.· 5+ years overall medical device experience· 5+ years' experience in quality assurance or engineering function· 3+ years support of a medical device in a quality engineering function· Understanding of Quality Systems requirements as outlined in CFR820/ ISO13485, and be able to communicate true requirements to cross-functional teams· Knowledge of medical device design control waterfall· Experience with utilizing a risk-based approach to quality systems processes· Demonstrated technical expertise and leadership in quality· Strong ability to communicate (written and verbally) within and across disciplines and organizational structures