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 team member to contribute to this dynamic project in our Cerritos Engineering Office. If you have strong organizational, leadership, and interpersonal skills then you should apply to join our energetic and diverse team. The Quality Assurance Manager will work to develop and implement a quality management system in accordance with ISO 13485, 21 CFR 820, and MDR 2017/745. Strong preference will be given to candidates with hands-on, professional experience working with FDA Class III Medical Devices.   RESPONSIBILITIES Lead development and implementation of in-house QMS Lead planning and implementing good manufacturing practice (GMP) and good laboratory practice (GLP) systems Co-leads (with R&D) in implementing Design Control: Conduct risk...

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...