Post Date: 3/25/20
Location: Irvine, CA | Pay: $120,000/year + bonus 15% / DOE
Shift: 9:00AM to 5:00PM; Monday to Friday
Employment Status: Full-time and direct-hire
Job Duties: Implements and manages quality system; Responsible for FDA and government regulations; Handles customer complaints for all products sold in North American countries and MDR reporting; Contact person to correspond with FDA about RA, QMS, PMS, MDR reporting and recall matters; Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers; Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, participating in professional societies
Requirements: Must have at least 5 years of experience as senior manager in quality systems; Must be able to travel 10% of the time; Previous R&D medical device experience is a plus; RAPS member is also a plus; Ability to work with mathematical concepts such as percentage change, profitability, margin analysis, fractions, ratios, etc.