Requires a four-year college degree and a minimum of seven years of related experience in a regulated industry. Must have a minimum of five years of experience in establishing and/or processing complaints and a minimum of 3 years of experience in a FDA regulated industry and adverse event reporting and a minimum of two years of supervisory experience. Intermediate computer software skills, i.e. Microsoft Office. Certifications from ASQC, CQM/OE, CQE, etc. preferred.