- Envista Holdings Corporation (Brea, CA)
- …Quality Engineer will report directly to the Quality Engineering Manager . **Job Requirements:** **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Actively participates ... and process changes. + Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards....Management (VPM)). + Any duties or tasks assigned by Supervisor/ Manager . **JOB REQUIREMENTS:** + Bachelor's degree (B. S.) in… more
- Adecco US, Inc. (Union City, CA)
- …along with other tasks as requested by the department supervisor or manager . This role requires clear knowledge of quality processes, specifically working within ... an **ISO 13485 and FDA regulated environment** . This position focuses heavily on...devices. 3. Technical experience, preferably in a **regulated environment** ( FDA , ISO 13485, etc.), that includes engineering drawings and/or… more
- Kelly Services (Petaluma, CA)
- …robust quality processes for future growth Key Responsibilities: + Assist the QA Manager in building, scaling and managing the QA team + Ensure regulatory compliance ... with GMP, FDA , ISO13485 and combination product requirements + Assist in...environment (combination product experience a plus). + Expertise in FDA regulations, ISO standards, drug/device compliance + BS/MS in… more
- Stanford University (Stanford, CA)
- …world of health care in the cancer arena. Reporting to the Clinical Research Manager , the Clinical Research Coordinator 2 will be conversant in the goals, mission ... investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* -… more
- Bayer (Bakersfield, CA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- Danaher Corporation (San Diego, CA)
- …current with strict regulatory and business requirements. This position reports to the Manager , Technical Writing & Training, and is an onsite role based in the ... guides, service guides, and instructions that strictly adhere to FDA , EU MDR/IVDR, and ISO 13485 requirements, ensuring all...knowledge of medical device regulations and quality standards, including FDA (21 CFR Part 820), EU IVDR/MDR, and ISO… more
- Abbott (Alameda, CA)
- …with current Quality System Requirements. + Works independently with objectives given by manager , planning and coordinating own work and work of others to high-level ... + Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate… more
- Stanford University (Stanford, CA)
- …5 or more studies, and work under the close direction of the manager (CRM), regulatory specialist and principal investigator(s). The CRCII will support industry, ... investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. +… more
- Abbott (Pleasanton, CA)
- …clinical, and programming assistance, primarily in support of 1-2 Territory Manager (s). + Assist Territory Managers in after-hours call support and activities. ... Proficient in complex programming, case support. + Works seamlessly with Territory Manager (s) allowing them increased selling time. + Will foster high trust… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Excellence & Operations Vendor and Contracts Management Lead and directly manages the Manager , HCP Engagement Lead. This position will lead the transformation of how ... and Operational Oversight** + Directly manage, coach, and develop the Manager , HCP Engagement Lead, overseeing their performance, workload, and adherence to… more