- Abbott (Pleasanton, CA)
- …in regulated industries (medical devices, pharma, healthcare). + Knowledge of FDA software validation processes. + Experience with real-time monitoring ... Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO 13485). + **Observability** :...into application design. + Work closely with QA and validation teams to support software verification and validation… 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
- 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
- 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
- Edwards Lifesciences (Irvine, CA)
- …Experience working in complex, matrixed and global business environment + Experience with FDA guidelines for Software Quality and Systems Validation required + ... by Leadership **What you'll need:** + Bachelor's degree in computer science or related field + 4 years of...in complex global business environment + Prefer experience with FDA guidelines for Software Quality and Systems Validation… more
- Stryker (San Jose, CA)
- …Medical Division. + Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance ... software lifecycle by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and development activities for… more
- ABM Industries (Carlsbad, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Understands and is aware of the ... in their area of responsibility, including product design, verification and validation , manufacturing and testing activities. + Serve as system administrator,… more
- Bio-Techne (San Marcos, CA)
- …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
- Abbott (Sylmar, CA)
- …with product strategy and market differentiation goals. + Lead data generation, validation protocols, and submission strategies for new FDA 510(k) AI-based ... bodies. **Qualifications** + Bachelor's degree required. Ph.D. required in Computer Science, Bioinformatics, Electrical Engineering, or related field. + AI/ML… 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
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