- Abbott (San Diego, CA)
- …Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems . + Assists with supplier ... related field. **Preferred Qualifications** + Masters degree preferred + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO… more
- Cognizant (San Francisco, CA)
- …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. + Ability to… more
- Abbott (Pleasanton, CA)
- … design and architecture, requirements definition and management, design documentation, and system testing, verification, and validation . **What You'll Work On** ... or related discipline + 8+ years of in a similar position, including systems engineering and integration experience (integrating all system components -… more
- Abbott (Pleasanton, CA)
- …related discipline + 8+ years of experience in a similar position, including system verification and validation , systems integration experience, software ... The Staff Systems Verification Engineer will be accountable for delivering system verification across the full CardioMEMS system in support of multiple… more
- VTI Life Sciences (San Diego, CA)
- …of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation ....Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as… more
- J&J Family of Companies (Santa Clara, CA)
- …must be inclusive of at least three (3) years leading GxP software validation projects. **Required Knowledge:** + Quality Systems + Working knowledge of ... GxP requirements and experience in non-product software validations. + Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part 820… more
- Abbott (Sylmar, CA)
- …On** + Work with Design and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create ... and execute or direct software validation protocols and reports traceable to system /software...skills and responsibilities of the position. + Knowledge of FDA Quality System Requirements and other applicable… more
- Abbott (Sylmar, CA)
- …issues. + Validation : Create and execute or direct software validation protocols traceable to system /software requirements. + Change Management:Implement ... + Work with Design and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create… more
- Abbott (Sylmar, CA)
- …procedures. **WHAT YOU'LL DO** + Work with R&D in the completion of system /software requirements and other verification and validation processes related to ... and 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 ... and production teams are adequately trained and ready to support new automation systems before deployment + Lead testing, validation , and documentation efforts… more