- BD (Becton, Dickinson and Company) (San Diego, CA)
- …how to deploy them in a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + ... a **maker of possible** with us. **Position Summary** The Senior Manager of EMI (Electromechanical Instruementation) Quality Sustaining Engineering reports to the… more
- Terumo Neuro (Aliso Viejo, CA)
- …coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties: + As ... with monitors/CROs to address and resolve queries. + Work closely with Project Manager (s) to ensure clinical studies are conducted in accordance with the protocol,… more
- CSL Plasma (Stockton, CA)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... company directives are adhered in order to support the operations and quality requirements for business operations ....implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent… more
- Vera Therapeutics (Brisbane, CA)
- …excellence. Critical partners for these activities include CMC & Clinical Operations . This person will oversee clinical and commercial supply chains, ensuring ... alignment with FDA /EMA standards, cold chain logistics protocols, and enterprise-wide risk...Leadership * Direct end-to-end direct and indirect supply chain/sourcing operations , including establishment of best practices for vendor selection… more
- Medtronic (Los Angeles, CA)
- …of strategies for field replacement units in collaboration with the RAS operations team and Principal technical Service Lead. This individual is considered an ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Sysco (Fremont, CA)
- …any manner capable of during emergencies the plant President or GM (general manager ) determines are paramount to the business. + Frequently interacts with the ... following: SSMC/SSSC Personnel, Operations , Sales, Transportation and Maintenance as well as Sysco...Formal job training in TQM principles, SPC, HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and… more
- Element Materials Technology (Santa Fe Springs, CA)
- …routine QA activities to ensure compliance with applicable regulatory requirements (eg, FDA 21 CFR Part 11, 210/211, ISO 17025) and internal quality standards. ... approval, and document control. Reports to the Quality Supervisor and/or Quality Manager . $25hr-$35hr DOE **Responsibilities** + Perform QA review of analytical data… more
- Caldera Medical (Westlake Village, CA)
- …Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager : We are seeking a strategic and hands-on Director of Quality to lead the Quality ... and commercial support. * Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDD/MDR, MDSAP, and...the Quality Management System (QMS), driving standardization across global operations . * Direct and develop quality strategies for new… more
- Cordis (Irvine, CA)
- …that our medical devices meet the highest quality standards throughout the operations and manufacturing process, as well as responsible for overseeing and managing ... operations quality programs, initiatives and guiding the ...potential for this position to assume the quality program manager on MDR. + Supplier Collaboration: Work closely with… more
- Amgen (Thousand Oaks, CA)
- …Product Technologies organization. Working with the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this role will ... that the site meets the quality requirements of its customers and applicable regulations ( FDA , EU & global standards). + Assist in the development of any existing… more