Quality Systems Manager needed for Katecho, Inc., a medical device manufacturer, to manage all aspects of the quality systems, including, but not limited to, maintaining the ERP software (IQMS), leading customer & regulatory audits, and partnering with production & senior leaders on quality processes. This position oversees the administrative quality team, as well as some product testing personnel and works closely with the VP of Quality, as well as the CEO. The ideal candidate would have experience in a medical device manufacturing, a Bachelor’s degree in a related field, familiarity with FDA 510K and PMA submissions.
Requirements for the positions include, but are not limited to, 5+ years working knowledge in a manufacturing environment, ability to lead and influence employees, have knowledge with ISO regulations, read, write and speak English, effectively communicate – written and verbally, be accurate and detail oriented, have above average attendance, and be a team player.
About Katecho, Inc.
Founded in 1984 and located in America’s heartland, Katecho is a privately held, internationally recognized, full-service contract manufacturer specializing in medical and cosmetic products.At Katecho, which is ISO 13485:2003 certified, we offer product design, process design, hydrogel production, printing, manufacturing, and logistics. Whether it is small volumes of hand-assembled products or highly automated computer-controlled fabrication, we provide quality manufacturing with on-time delivery.Plus, we employ the most talented engineers, product testers, lab technicians, designers, and assemblers in the industry. Our dedicated employees work hard every step of the process — from initial concept to final packaging — to add value to your bottom line.