- J&J Family of Companies (Santa Clara, CA)
- …superior components and services. + Authors and executes process and system specifications, validation and test protocols and validation and test reports. + ... methodology. + Support the transfer of product lines and the qualification- validation efforts. + Evaluates existing engineering processes and recommends improvements… more
- Abbott (Pleasanton, CA)
- …test strategies and practices align with medical device regulatory standards ( FDA , ISO, IEC 62304).Support documentation, verification, and validation processes ... automation frameworks for functional, integration, regression, system, and end-to-end validation .Build and maintain reusable test libraries, tools, and pipelines… more
- AbbVie (Irvine, CA)
- …of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of ... Able to critically review SDTM conformance mapping specifications. + CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml… more
- Abbott (Alameda, CA)
- …ensure manufacturing tests are adequate *Reviews and contributes to test method validation protocols *Specifies and develops test fixtures for PCBA functional test, ... + Extensive Knowledge of regulations for medical device development (ISO134851, ISO13485, FDA ) is a plus. Extensive understanding of processes and materials used in… more
- Imperative Care (Campbell, CA)
- …to assess product requirements, reviewing studies product characteristics to select validation objectives and standards. Seek and provide supplier feedback on DFMs. ... Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, GMP, GDP procedures and requirements. +… more
- Actalent (Irvine, CA)
- …responsible for ensuring compliance with internal and external regulatory requirements, including FDA , ISO, and MDD standards. You will play a pivotal role in ... product development lifecycle, including risk management and design/process verification and validation . + Applied knowledge of Advanced Quality tools such as FMEA,… more
- Cordis (Irvine, CA)
- …standards and company requirements. + Ensure supplier processes align with ISO, FDA , and other regulatory requirements. + Provide guidance to suppliers on quality ... or a related role. + Strong knowledge of supplier qualification, component validation , and quality systems. + Experience conducting supplier audits and working with… more
- Abbott (Alameda, CA)
- …investigations. + Responsible for tracking all returned product, calibration and proper validation of all test equipment within the lab. + Assists Lab Supervisor ... investigations in a regulated environment and knowledge of the FDA /QSR regulation and ISO 13485 standard is required. +...Complaints investigations are a primary focus of corporate and FDA audits. + Investigations that are not conducted or… more
- Sutter Health (Santa Rosa, CA)
- …policies and department standards. + Completes all annual competency validation requirements. + Participates in quality improvement processes, including updating ... Drug Enforcement Administration (DEA), and the Food and Drug Administration ( FDA ) by monitoring nursing unit inspections; maintaining records for controlled… more
- Kelly Services (Orange County, CA)
- …across multiple projects. + Ensure strict adherence to **industry regulations** (eg, FDA , GMP, ISO) and **company policies** . + Conduct **regular audits, ... issues and improve processes. + Assist in the creation and execution of ** validation protocols** and **testing procedures** . + Prepare and review critical **quality… more