- Cordis (Irvine, CA)
- …implement practical business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation ... (PLM). You'll map business processes end-to-end, translate them into system requirements, and lead continuous improvement initiatives that boost productivity,… more
- Meta (Burlingame, CA)
- **Summary:** We're seeking a Product Verification and Validation Engineer to join our medical devices compliance team, focusing on wearables and Software as a ... and reliability of our products, particularly in areas such as:* Sensor validation : Working with advanced sensors, such as electrodermal activity (EDA) sensors,… 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
- Nestle (Los Angeles, CA)
- …for supporting the Vowst and Microbiome Sciences team with systems upgrades, computer system validation activities, and system administrative ... LIMS, MES, ERP). * Collaborate with Information Technology (IT), Computer System Validation (CSV), and... (QAV) in maintaining integrity and control of designated computer systems . * Monitor system … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO ... processes, ensuring seamless integration with SAP S/4HANA and other related systems (SFHC - upstream, MES, Robar/Bartender - downstream) and driving business… more
- Abbott (San Diego, CA)
- …role oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... problems of moderate scope. Participate in software development, verification, and validation activities under guidance Adhere to FDA -compliant Design Control… more
- Terumo Neuro (Aliso Viejo, CA)
- …method validation and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven experience in ... risk assessments and FMEAs. + Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal… 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
- Abbott (Alameda, CA)
- …oversees the design, development, and validation of software for embedded systems , ensuring compliance with FDA requirements. They play a crucial role ... addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control… more
- ABM Industries (Carlsbad, CA)
- …Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + ... and validation , manufacturing and testing activities. + Serve as system administrator, maintain, troubleshoot, and program site trending and monitoring … more