2 jobs found

BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated experienced Quality Engineer team member to contribute to this dynamic project in our Huntington Beach Office CA. The Quality Engineer (QE) will support preparation and review of documentation and inspection required for manufacture and test of the Total Artificial Heart (TAH) system and will work with the team to assist in implementing a QM system in accordance with ISO 13485 and 21 CFR 820. The QE will work on daily Quality Assurance (QA) activities by supporting creation and review of work instructions, inspection instructions, test protocols, and process Design Change Orders (DCO). The QE will also support inspection activities both internal at BiVCOR and its suppliers. The QE will work closely with the internal engineering staff to the support...

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...