- Stryker (Menlo Park, CA)
- …looking for an experienced and highly skilled Senior Staff AI Data and Validation Engineer. A successful candidate will be responsible for developing methods and ... of AI/ML models used in medical devices, ensuring compliance with all applicable FDA guidelines and regulations. This role is crucial for maintaining the safety,… more
- Abbott (San Diego, CA)
- …people in more than 160 countries. **Lead Design Quality Engineer - Software** ** Validation ** **Working at Abbott** At Abbott, you can do work that matters, grow, ... and cancers. As the **Lead Design Quality Engineer - Software Validation ** , you'll reviews documentation for accuracy, clarity, consistency, completeness and… more
- Cognizant (San Francisco, CA)
- …+ Understanding of Pharma value chain, Products/ Platforms used. + Knowledge of FDA regulations for Computer system validation , Medical Device regulations, ... GAMP 5 + Knowledge of Test Automation, Understanding of Gen AI will be a plus. + Experience and proven track record of dealing with IT, business, C level executives. + Well-rounded consultant with the ability to cross-sell, up-sell across all functional areas.… more
- VTI Life Sciences (San Diego, CA)
- …the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity,...Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and regions. _Job Summary:_ Write, review and approve submissions to the FDA and other regulatory agencies and coordinate completion of the technical documentation ... required to meet submission timelines. Review and approve Validation and Research & Development documents. Perform compliance reviews of Validation CAPAs for… more
- Abbott (Sylmar, CA)
- …Engineering in the completion of system/software requirements and other verification and validation processes. + Create and execute or direct software validation ... Integrity assessments and Risk Analysis assessment to comply with FDA 21 CFR Part 11. + Participate in reviews...aptitude to use various types of databases and other computer software. Strong organizational skills. Ability to prioritize. Ability… more
- J&J Family of Companies (Santa Clara, CA)
- …associated procedures for non-product software compliance assessments and validation of non-product software, ensuring compliance with regulatory requirements ... are established and maintained. Supports establishing and maintaining the validation master plan for non-product software applications for Shockwave. Serves… more
- Abbott (Sylmar, CA)
- …of FDA , GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including tatistical/data analysis and report writing skills. Advanced Information Technology ... maintenance. + Documentation: Develop and maintain documentation in compliance with FDA , ISO, and other regulatory requirements. Apply sound, systematic problem… more
- Abbott (Sylmar, CA)
- …R&D in the completion of system/software requirements and other verification and validation processes related to embedded software products. + Participate in reviews ... provide useful feedback. + Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time… more
- Medtronic (Santa Ana, CA)
- …for establishing best practices and standards for the design, development, and validation of automation systems. Beyond technical execution, this role will drive ... with broader business and operational objectives. Familiarity with regulated environments ( FDA , GMP, ISO 13485) and awareness of Industry 4.0 technologies (IIoT,… more