- 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 (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
- Stryker (San Jose, CA)
- …and ensure compliance with internal procedures and regulatory standards (eg SOC 2, ISO, FDA and HIPAA) **What you will do:** + Support software product teams by ... regulatory and compliance frameworks (eg, SOC 2, ISO 27001, FDA 21 CFR Part 11, HIPAA, ISO 13485). +...and external SOC2 audits + Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and… 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
- 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 (Alameda, CA)
- …software quality standards across the development lifecycle, including validation , verification, risk management, cybersecurity, and documentation practices. + ... and execute regulatory strategies for software-enabled medical devices, ensuring alignment with FDA , EMA, EU MDR, ISO 13485, and other relevant frameworks. Navigate… more
- J&J Family of Companies (Santa Clara, CA)
- …teams to identify opportunities for improvement + Assure data integrity and data validation prior to publishing reports and analysis + Process confidential data and ... + Support company goals and objectives, policies, and procedures, QSR, and FDA regulations + Other duties as assigned **An internal pre-identified candidate for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …resource, budget, and program milestones. + Working knowledge of lab automation, computer validation , data governance, data science, knowledge management and ... development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key… more
- Sutter Health (Berkeley, CA)
- …policies and department standards. + Completes all annual competency validation requirements. + Participates in quality improvement processes, including updating ... Drug Enforcement Administration (DEA), and the Food and Drug Administration ( FDA ) by monitoring nursing unit inspections; maintaining records for controlled… more
- Abbott (Alameda, CA)
- …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... determine appropriate action. **Required Qualifications** + Bachelor of Science in Computer Science, Engineering Mathematics, or related field. MS desired. + Minimum… more