- 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
- 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
- Abbott (Pleasanton, CA)
- …analysis and postmortems, driving continuous improvement. + **Compliance & Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO ... in regulated industries (medical devices, pharma, healthcare). + Knowledge of FDA software validation processes. + Experience with real-time monitoring… more
- BeOne Medicines (San Carlos, CA)
- …join our Clinical Biomarker laboratory. This role will lead the development, validation , and execution of quantitative and qualitative mass spectrometry assays to ... well as hands-on experience in mass spectrometry-based biomarker method development, validation and clinical sample analysis. **Essential Functions of the job:** +… more
- Abbott (Temecula, CA)
- …design change projects + Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation ... + Lead design test and inspection method development, and lead method validation activities + Ensure DHF content completion, integrity, and regulatory & standards… more
- Abbott (San Diego, CA)
- …to the development, implementation and effectiveness of the Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Understands ... clear and accurate records of experiments in a laboratory notebook and engineering/ validation reports. + Generate and present projects, both in depth and high… more
- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more
- Stryker (San Jose, CA)
- …validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements. + Partner with cross-functional teams, including ... software lifecycle by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and development activities for… more
- Abbott (Alameda, CA)
- …**What you'll work on** + Lead software development, verification, and validation ; responsible for on-time delivery of high-quality embedded software biowearable ... approved design control procedures for software development in accordance with FDA guidelines. + Lead software development projects, providing mentoring and… more
- Abbott (Sylmar, CA)
- …What You'll Work On + Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to ... requirements + Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements + Assist in… more
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