- Cordis (Irvine, CA)
- …+ Develop, and qualify new tooling and equipment. + Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. ... * Ability to make independent decisions * Knowledge of validation verification process, Gage R&R, and a clear understanding...verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP * Basic proficiency in SolidWorks… more
- J&J Family of Companies (Santa Clara, CA)
- …(systems, software, hardware, clinical, quality, etc.). + Support regulatory documentation and validation (eg, FDA 510(k), risk analysis). + Lead code reviews, ... are required: A.) a BS degree in a technical discipline (eg Computer Science, Computer Engineering, EE, ME, or equivalent) combined with 6 years of relevant… more
- Terumo Neuro (Aliso Viejo, CA)
- …path. 6. Familiarity of software testing methods, including principles of formal computer software validation (CSV). Knowledge of medical device software ... **Department Name:** 105-Information Technology **Qualifications:** 1. Bachelor's degree in computer science, Information Systems Management, Business, Engineering, or related… more
- J&J Family of Companies (Santa Clara, CA)
- …and resources. * Support developing the test cases for the verification and validation of the Service functionalities. Advice on the execution of those tests. * ... in the medical devices industry, basic knowledge of working in an ISO and FDA regulated environment is a plus. Johnson & Johnson is an Equal Opportunity Employer.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Programming Oversight & Technical Excellence** + Oversee the design, development, validation , and maintenance of SAS macros, scripts, and applications supporting ... programming infrastructure is robust, scalable, and compliant with regulatory standards (eg, FDA 21 CFR Part 11, GxP), and supports reproducibility and audit… more
- Gilead Sciences, Inc. (Foster City, CA)
- …analyses, and ultra-performance chromatography. + Working knowledge of lab automation, computer validation , data governance, and data protection. + Strong ... understanding of FDA and ICH guidelines for biologics registration and compliance. **Communication & Collaboration** + Demonstrated ability to mentor junior… more
- Abbott (Sylmar, CA)
- …correctness. + Ensures compliance with US Food and Drug Administration ( FDA ) regulations, other regulatory standards, company policies, operating procedures, and ... within larger initiatives-such as user needs analysis, feature definition, validation , or subsystem development-and drives them to timely, high-quality completion.… more
- Stanford University (Stanford, CA)
- …data systems for research projects, including database design, data collection, validation , analysis, and reporting. + Develop project timelines, targets, and ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- Abbott (San Diego, CA)
- …implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE: * ... Bachelor's degree in Computer Science or Engineering; Master's or doctoral degree preferred....the area of responsibility, including product design, verification and validation , manufacturing and testing activities * Responsible for exhibiting… more
- Cardinal Health (Sacramento, CA)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more