Business Operations Manager

OralKleen is a Phoenix-based medical device company developing innovative oral care products for dependent individuals across the continuum of care—from mechanically ventilated ICU patients to dependent patients in the home setting. Position Summary The Business Operations Manager is a critical leadership role responsible for overseeing the full scope of OralKleen’s operational backbone: Supply chain/supplier management, Inventory management, Clean-room kitting and The company’s Quality Management System (QMS). This role is integral to ensuring that OralKleen delivers safe, compliant, high-quality medical devices reliably and efficiently to customers. This individual will architect, implement, and continuously improve OralKleen’s QMS to meet FDA QSR requirements, manage global contract manufacturers and suppliers, oversee shipping and fulfillment, and lead customer-facing operations such as complaint handling and call center processes. The ideal candidate is a gritty, resourceful, self-directed operator who thrives in a lean startup environment, is adept at solving problems with imperfect information, and is motivated by building scalable processes from the ground up. This role requires hands-on execution, strong judgment, and the ability to take full ownership of operational outcomes. Experience, Skills & Qualifications Required or Strongly Preferred: Phoenix-based role Experience in a startup or small-company environment. Experience in medical device, healthcare manufacturing, or FDA-regulated products. Hands-on experience with QMS development and ongoing quality assurance. Demonstrated success managing domestic and international suppliers. Logistics and freight movement expertise, including inbound international shipping. Strong documentation, reporting, and process-building capabilities. Ability to prioritize, multitask, and meet deadlines across multiple projects. Preferred: Bachelor’s degree in business, engineering, supply chain, manufacturing, or related field. Experience with ISO standards, CAPA processes, and design controls. #J-18808-Ljbffr