2 jobs found

Welcome to ZiphyCare! We're grateful you're interested in learning more about us to consider joining our team. At ZiphyCare, we are challenging the status quo in healthcare delivery. We believe that cost-effective quality healthcare can be delivered directly to every home. We are looking for a Director of Commercial Manufacturing who will Direct the research and development in order to meet the commercialization schedule.  Scale up the current production processes to establish the production of Ziphy kits on-demand, on time. Manage relationships with parts suppliers, vendors and factories producing metal, plastic, foam and other parts. Manage the current process with the emphasis on producing documentation for CMs. Support the company's efforts as necessary to obtain ISO 13485 certification and CE Mark for its products. Actively participate in and perform duties for the company’s QMS and regulatory audits.  This is a remote position with some...

Welcome to ZiphyCare! We're grateful you're interested in learning more about us to consider joining our team. At ZiphyCare, we are challenging the status quo in healthcare delivery. We believe that cost-effective quality healthcare can be delivered directly to every home. We are looking for a Medical Device QMS Specialist who Will be responsible for the daily execution of the Quality Management System (QMS). Will work closely with quality and regulatory consultants. Will work with Contract Manufacturers’ quality, including overseeing supplier quality audits. Shares information and data that the leadership team informed and educated on quality and compliance concerns.  Responds to all concerns with data driven and informed independence, and thorough action to assure the success of the company. This is a remote or office with periodic travel position, and the scope of work will include: leading the document control, design control and risk analysis for...