- Biomat USA, Inc. (Moreno Valley, CA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and...is performed. + Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Stanford Health Care (Palo Alto, CA)
- …Ensures organizational compliance with federal/state regulations and accreditation requirements ( FDA , CDPH, BOP, TJC, etc.) for medication management. Develops audit ... managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample medications, investigational studies,… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure Quality incidents ... and training in assigned area. The Field Quality Assurance Manager is accountable for continuously working to improve quality...with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations… 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 (Fairfield, CA)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... the development and implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during… more
- Element Materials Technology (Santa Fe Springs, CA)
- …Acting as a key link between the laboratory teams and the Quality Manager , this role ensures that all testing activities are executed with accuracy, efficiency, ... role requires a deep understanding of GMP, ISO 17025, FDA , and ICH requirements, as well as the ability...the primary liaison between laboratory staff and the Quality Manager to ensure alignment on priorities and deliverables +… more
- Fujifilm (Sacramento, CA)
- …the assistance of technical support, as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Medtronic (Los Angeles, CA)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Envista Holdings Corporation (Pomona, CA)
- …Sr. Quality Engineer will report directly to the Quality Engineering Manager . **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Actively participates in defining customer ... the current process and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards. + Documents data obtained… more
- Medtronic (Irvine, CA)
- …and author new process documents + Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct + ... + Excellent communication & organizing skills + Knowledge of FDA , EU, and TGA requirements + Knowledge of Neurovascular...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more