4 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...

Sepset Biosciences Inc. seeks applications for an experienced quality assurance (QA) and regulatory affairs manager or consultant to help with the development and regulatory approval of Sepset’s medical diagnostic test for sepsis. The QA manager will report to the CSO and work closely with senior management and company employees to implement and maintain an eQMS system as well as ensure regulatory compliance. The individual will also make sure that company leadership is engaged in quality management practices and training to ensure that company objectives regarding quality and risk management are successfully met. Qualifications and Experience MSc or PhD in biomedical engineering or biomedical science (BSc with extensive medical device development and quality management experience may also be considered). QA or regulatory affairs training an asset. At least 4 years experience working in the medical device field. Knowledge of medical diagnostic test technology,...

Job Summary The Quality Assurance (QA) Manager is responsible for the daily execution of the Quality Management System (QMS). The Manager works closely with the CMSO, CTO, COO, Chief Legal Officer and Chief Success Officer to execute on quality objectives. Works closely with quality and regulatory consultants but remains a good steward of limited financial resources. Interfaces with Contract Manufacturer quality, manages/triages installer and customer feedback, executes supplier quality audits, and manages related quality engineers. Ensures that the leadership team remains informed and educated on quality and compliance concerns and responds to all concerns with independence and thorough action to assure the success of the company. Responsibilities, Role and Function The QA Manager is responsible for the following: Daily execution of the QMS Collaborate with internal and external Engineering teams to ensure QMS processes are followed throughout the product...