3 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...

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...

The Manager of Operations/Quality Affairs, will be responsible for providing operational and quality leadership both strategically and in day-to-day activities. This individual will have sole responsibility for regulatory compliance related activities such as supplier management, change controls, deviations and general QMS maintenance. This individual will also ensure that the QMS and all business activities are in compliance with applicable US and international regulations and will be responsible for planning activities to ensure continued compliance.  This role requires the ability to develop and maintain cooperative working relationships with team members to effectively ensure compliance and timeliness of both (vendor) manufacturing and regulatory activities.   Responsibilities Manage the QMS to include CAPAs, Post-Market Surveillance, Training, Document and Change Control and Record Management. Manage audits (supplier audits as well as third-party, notified body or...