- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Primary Duties and Responsibilities** + May ... in the development and maintenance of clinical trials management systems including validation of systems. + May train clinical research staff to help improve… more
- Fujifilm (Sacramento, CA)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- General Atomics (Poway, CA)
- …reports and SOPs, responsible for assay performance data collection, assay validation and documentations needed for FDA submissions; manufacturing practices ... post launch product activities including going to the customer sites for validation **DUTIES & RESPONSIBILITIES:** + Participate in the development of operating… more
- Abbott (Alameda, CA)
- …of automation solutions. **Data Integrity, Governance & Analytics:** + Implement data validation and monitoring processes to ensure data integrity across systems. + ... and support continuous improvement initiatives. + Implement robust data validation processes to support reliable decision-making. + Utilize data analytics… more
- Philips (San Diego, CA)
- …internal policies throughout the software lifecycle. + Authorizes/Leads the assessment, validation and approvals of software designs/inputs, overseeing the review of ... and Ensures Risk Management is effective utilizing feedback from validation , field service, post market surveillance, manufacturing indicators, CAPAs, HHAs,… more
- Cordis (Irvine, CA)
- …+ Develop, and qualify new tooling and equipment. + Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. ... * Ability to make independent decisions * Knowledge of validation verification process, Gage R&R, and a clear understanding...verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP * Basic proficiency in SolidWorks… more
- Cedars-Sinai (Los Angeles, CA)
- …and work with bioinformatics to develop and maintain trial management and validation systems. Ensures compliance with all federal and local agencies including the ... Food and Drug Administration ( FDA ) and local Institutional Review Board. **Primary Duties and...development and maintenance of clinical trials management systems including validation of systems, as needed. + Train clinical research… more
- BeOne Medicines (San Mateo, CA)
- …of staff in support of clinical trials, ad-hoc analysis requests, data validation , etc. in accordance with all relevant statistical regulatory guidance and ... follow specifications to create SDTM and ADaM datasets (as needed)** ** Computer programming using SAS** **Fundamentals of project planning and management** **Drug… more
- J&J Family of Companies (Santa Clara, CA)
- …(systems, software, hardware, clinical, quality, etc.). + Support regulatory documentation and validation (eg, FDA 510(k), risk analysis). + Lead code reviews, ... are required: A.) a BS degree in a technical discipline (eg Computer Science, Computer Engineering, EE, ME, or equivalent) combined with 6 years of relevant… more
- Stryker (San Jose, CA)
- …Healthcare IT or Systems Engineering **Preferred:** + Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer ... Security Risk Assessments and defect management, software testing and/or verification/ validation . + Previous employment at leading technology companies such as… more