- KIK Consumer Products (CA)
- …and maintenance of all Incoming Component standards in compliance with FDA regulatory + Organization of calibration program for department instruments. Ensure ... of training programs + Special projects as assigned by the QA Manager + Develop strong working relationship with cross functional departments and employees… more
- Abbott (Alameda, CA)
- …barriers/obstacles to achieving agreed upon goals and escalate as needed to Training Manager . + Help to conduct training needs assessments and gap analysis. + ... training needs into QA training/learning solutions in line with project timelines. + Facilitate regular meetings with team and...+ Minimum 5 years in Medical Device or other FDA regulated industry experience. + Minimum 2 years in… more
- Medtronic (Los Angeles, CA)
- …evidence plan including Real-World Evidence is available at launch to support FDA approval and formulary coverage. + Provides strategic support to the Diabetes ... of US health insurance and the US health care payment system + Project management experience; demonstrated consultative mindset + Proven ability to work effectively… more
- Fujifilm (Sacramento, CA)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Danaher Corporation (West Sacramento, CA)
- …laboratory's role in improving healthcare outcomes. You will report to the Manager Technical Process Engineering, who is responsible for the Engineering and VAVE ... project team for Microbiology. If you thrive in a...etc.). + Computer Aided Design + Experience with ISO13485, FDA , and IVDR manufacturing systems. Join our winning team… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …and technical QA staff. * Deep knowledge of global medical device regulations ( FDA , EU MDR, etc.). * ASQ certification (Engineer or Manager ) preferred. ... Green Belt or Black Belt certification preferred. * Experience in manufacturing, project management, or engineering is a plus. * International experience and ability… more
- Cordis (Irvine, CA)
- …for MDR, with potential for this position to assume the quality program manager on MDR. + Supplier Collaboration: Work closely with supplier engineering group to ... practices. + Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing… more