- Beckman Coulter Diagnostics (Miami, FL)
- …with 3+ years of experience, OR Doctoral degree in fieldExperience in software , test method, equipment, process, and/or design testing methodologies.Knowledge of ... FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System Validation (CSV) and process validationIt would be a plus if you also possess… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of multi-tenant, cloud-based architectures. A background with Class I or Class II FDA software medical devices is desirable, as the Pyxis products span ... us. We are seeking highly motivated, self-directed, and experienced in software development for **cloud-based applications (AWS, Azure, GPC, etc.)** and… more
- Abbott (Alameda, CA)
- …or embedded firmware under a disciplined product development process that meets FDA requirements. \# software **What** **you'll** **work on** + Works ... products that meet budgetary objectives. + Implement approved Design Control procedures for software development in accordance with FDA guidelines. + Lead … more
- Bio-Techne (Wallingford, CT)
- …medical devices; knowledge of standards: GAMP 5, FDA GMP + Experience with FDA regulations for software validation and 21CFR compliance + Ensure that all ... new insight into proteins and their role in disease. Software is vital to our success in developing award...an opportunity to work with state of the art software /hardware technologies amongst a very creative, motivated, and talented… more
- Edwards Lifesciences (Naperville, IL)
- …to work independently and proactively in a fast-paced environment. + Prefer experience with FDA guidelines for Software Quality and Systems Validation is a plus ... collaboration with the Sustaining Engineer and Product Owner, this position provides technical/ software expertise to the product team. This position works on both… more
- Abbott (San Diego, CA)
- …Follow approved design control procedures for product development in accordance with FDA guidelines + Direct the software engineering group, providing mentoring, ... mothers, female executives, and scientists **The Opportunity** Directs the software engineering function in developing, releasing, and maintaining PC application… more
- Abbott (Columbus, OH)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Experienced in ... the CAPA management system + Develop, execute and review FDA validation protocols and related documentation in accordance with...concerns in a timely manner + Comply to all FDA policies and standards + Use M-Files to house… more
- Stryker (Portage, MI)
- …accordance with internal software development lifecycle requirements in compliance with FDA software development guidance. + Supports the research and design ... hardware using oscilloscopes, logic analyzers, and other hardware tools. ** Software Engineering/Computer Science Majors:** + Support development of procedures and… more
- Abbott (Casa Grande, AZ)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with ... supervisor **You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures.** **Required Qualifications** +… more
- Corza Medical (Parsippany, NJ)
- …financial regulations, reporting standards, and supply chain best practices. + Ensure FDA software validation compliance for ERP-related processes in regulated ... environments. + Documents processes or set of procedures for user instructions, standard operating procedures, technical archives or audits. + Managing outside consultants as well as managing their time. **What you will need** + Bachelor's degree in… more
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