- 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
- ABM Industries (Irvine, CA)
- …the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. Understands and is aware of the quality ... their area of responsibility, including product design, verification and validation , manufacturing and testing activities. Serve as system administrator, maintain,… more
- Stryker (San Jose, CA)
- …Analysis (sFMEA), Security Risk Assessments and defect management, software verification/ validation . **Preferred:** + Bachelor's degree in Computer Engineering, ... Medical Division. + Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance… more
- Abbott (Alameda, CA)
- …**What you'll work on** + Oversees software development, verification, and validation ; responsible for on-time delivery of high-quality embedded software biowearable ... Implement approved design control procedures for software development in accordance with FDA guidelines. + Play a critical role in software development projects,… more
- Abbott (Milpitas, CA)
- …the development, verification, ensuring timely delivery and adherence to FDA -compliant design control procedures. They provide technical leadership, mentoring, and ... **What you'll work on** + Lead software development, verification, and validation for embedded biowearable products, ensuring on-time delivery within budget. +… more
- Actalent (Irvine, CA)
- …product development activities, and supporting the design verification and validation processes. Responsibilities + Develop quality assurance documentation to ... and manufacturing processes. + Define and support design verification and validation test requirements to ensure objective evidence meets acceptance criteria. +… 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 (Pleasanton, CA)
- …Drive design reviews and enforce best practices for requirements traceability, validation , and compliance throughout the development lifecycle. + Organizes and ... and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and… more
- Bayer (Berkeley, CA)
- …including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits; * Ability to ... and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation , and Quality Systems (Deviation and CAPA management, Change Control,… more
- Abbott (Santa Clara, CA)
- …development and delivery, including data ingestion, feature engineering, training, validation , deployment, and monitoring. + Architect a highly available, secure, ... reviews. Required Qualifications + Bachelors Degree ( +/- 16 years) in Computer Science, Engineering Mathematics, or related field + Minimum 10 years with… more