BiVACOR Inc

BiVACOR® is a privately held company founded in 2008. Our staff includes world-class engineers, medical specialists, and business executives, who are diligently working to advance this ground-breaking technology. Together, we have established a strong collaborative network that extends both nationally and internationally. Our world headquarters is located in Houston, Texas, USA, and our international office is in Brisbane, Australia.

Jun 06, 2022  
$70,000 - $90,000 yearly
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...
BiVACOR Inc Full time
Jun 06, 2022  
$110,000 - $130,000 yearly
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...
BiVACOR Inc Full time