4 jobs found

Position Summary: As a Medical Device Software Quality Engineer, your primary job focus will be designing, implementing, and extending the medical device quality processes for Ceevra software that generates and displays 3D models of patient anatomy. Local candidates are preferred, although we’ll consider highly qualified remote candidates. If local, we envision 3 days/week in our SF offices (or more if preferred by the candidate). Responsibilities Drive quality-focused design and development of Ceevra software, including defining appropriate requirements, and creating and executing verification and validation plans and protocols Maintain and extend Ceevra’s Quality Management System Oversee various quality management activities, such as management reviews, internal audits, and external audits Develop quality practices applicable to cutting edge technologies with evolving regulatory guidelines such as Machine Learning Requirements At least three years...

Desktop Health is leveraging additive manufacturing and advanced materials to personalize patient care. Desktop Health is vertically integrated to develop, manufacture and commercialize applications across a range of healthcare specialties. The company is rapidly focused on leveraging its bio printing capabilities across several key specialties. Position Description: The Quality Assurance Manager will work with an interdisciplinary team to document the design and commercial manufacturing process of novel 3D printed tympanic membrane grafts (PhonoGraft) and other tissue grafts as part of the Desktop Health team. We are a small team located in Boston, MA (parking available), working to improve the lives of people with tympanic membrane perforations and other medical conditions. The candidate will work under the direct supervision of the Vice President of Biomaterials and Innovation, with support from a Manufacturing Engineer, a Mechanical Engineer, a Material Engineer, and...

Provide total quality and regulatory management and oversight for all aspects of ABM activities. Duties and Responsibilities: Establish clear outcomes and reliable milestones for all regulatory projects executed for and on behalf of ABM. Responsible for “bullet-proof” regulatory compliance in all aspects of operations, product development and acquisitions. Oversee the regulatory and quality team members as their activities and responsibilities relate to ongoing regulatory projects. Attend weekly Executive team, Staff, Regulatory, and Product Development meetings and other meetings as required. Participates in all aspects of the ABM Executive Team and staff to fully execute tasks to achieve ABM’s mission, goals and objectives. Ongoing Work Projects: Fully compliant regulatory systems USFDA QSR USFDA CGMPS ISO 13485 Canadian Medical Device Regulations – Medical Device Single Audit Program CE Marking from Medical Device Directive IMCAS...

Full Job Description: Enable Biosciences is an award-winning UC Berkeley/Stanford spun-out medical device company where we believe in providing affordable and accessible tests to empower timely diagnosis and treatment of difficult diseases. Based in South San Francisco, Enable leverages its patented ultrasensitive ADAP (Antibody Detection by Agglutination-PCR) technology to detect trace quantities of immunological biomarkers at the earliest treatable stage. Enable has been proudly offering its ADAP assays not only in its 10000 sqft CLIA/research lab but also in renowned institutes worldwide. Excellence of our products and service has been published in numerous peer-reviewed journals. Notably, Enable is proudly working with government entities to provide first-of-its-kind COVID19 testing service to support state-wide monitoring of disease prevalence and vaccination in the California. Enable Biosciences is seeking an experienced full-time Manager, Quality Assurance to join our...