- Abbott (Alameda, CA)
- …data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Participate in cross-functional clinical team(s) ... and Reports). + May interact with RA/QA in responding to audits and FDA inquiries. + Perform other function-related activities in addition to the responsibilities as… more
- AbbVie (Irvine, CA)
- …system. May be required to prepare and present data during regulatory audits ( FDA , EMA, Anvisa, etc) and internal audits. *Interact with internal and external ... the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations . + Knowledge and familiarity with product, process, equipment, and… more
- Danaher Corporation (West Sacramento, CA)
- …customer service and support for our on-site employees and manufacturing operations . This position reports to the Sr. Manager Engineering/Maintenance/Facilities ... in: + Manufacturing/Production environment, medical device manufacturing and/or other FDA -regulated industry and certifications in Electrical, Mechanical, Welding, or… more
- Envista Holdings Corporation (Pomona, CA)
- …other personnel involved in automation control systems. + Collaborate with project manager , mechanical design engineer and software group to develop a low-risk and ... Assist with performing process failure mode effects analyses. + Work with Operations and outside Vendors to create methods/process to improve capacities with… more
- KIK Consumer Products (CA)
- …at KIK** As a QA Supervisor-2 nd Shift, you will oversee quality assurance operations in a chemical manufacturing environment. This is a 2 nd shift position with ... and maintenance of all Incoming Component standards in compliance with FDA regulatory + Organization of calibration program for department instruments. Ensure… more
- Medtronic (Irvine, CA)
- …guidelines, and standards + Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements + Participate in internal ... submissions and other worldwide submissions and clearances. + Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485,… more
- Moonlight Companies (Reedley, CA)
- …see what we're made of. Job Summary Assist the Food Safety Manager to coordinate, develop, implement the food safety/security regulations, policies and procedures ... for packing, cooling and farming operations . Responsibilities and Duties + Assist with training for...safety experience, knowledge and experience with HACCP, USDA, or FDA preferred. + Previous experience with SQF, GFSI, Primus,… more
- Danaher Corporation (Sunnyvale, CA)
- …Quality, and other Quality related functions. This position reports to the Sr. Manager Regulatory Compliance and Post Market Surveillance and is part of the ... related work experience. + Functional knowledge of Quality, Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for… more
- Abbott (Alameda, CA)
- …listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager /Study Lead as needed. + Proactively and effectively communicate ... of regulatory submissions. + May interact with RA/QA in responding to audits and FDA inquiries. + Perform any other duties as assigned by management. + Must be… more
- Danaher Corporation (West Sacramento, CA)
- …Additionally, as the Senior Process Engineer, you will lead Technical Operations projects, including process validations and post-launch design changes, serving as ... in improving healthcare outcomes. You will report to the Manager Technical Process Engineering, who is responsible for the...etc.). + Computer Aided Design + Experience with ISO13485, FDA , and IVDR manufacturing systems. Join our winning team… more