- Abbott (Sylmar, CA)
- …combination of education and work experience. + Minimum 7 years of Software Quality Engineering experience. + Detailed knowledge of FDA , GMP, IEEE 1012 and ... or irregular heartbeats. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality … more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …communication and data handling. + Regulatory Compliance: Design software with FDA , QSR, and ISO quality system regulations in mind, ensuring adherence ... with structured software development methodologies (Agile, Scrum) and maintaining software quality within a regulated environment. + Technical Leadership:… more
- Abbott (Burlington, MA)
- …health and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance ... oversight for Software Development projects. The **_Staff Software Quality Engineer_** is responsible for executing...FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and… more
- Abbott (Alameda, CA)
- …+ 5 to 8 years' experience in Software Quality Assurance and/or Software Testing experience. + Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR ... + Participate as a lead member of the Non-Product Software Quality Assurance (SWQA) team for Abbott...of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... understanding of medical device software standards such as IEC 62304. ** Software Quality Engineering Expertise:** 1. Hands-on experience in Software … more
- Stryker (San Jose, CA)
- **Stryker** is hiring a **Staff Software Quality Engineer, Post Market** to support our Medical's Digital Health division and portfolio Software as a Medical ... Partner with the Professional Services and Technical Support Organization to ensure quality customer outcomes through software solution installation and tech… more
- Stryker (Portage, MI)
- **Stryker** is hiring a **Staff Software Quality Engineer, Design Assurance** to support our Medical's Digital Health division and portfolio Software as a ... (SiMD) to execute on Digital Health projects as a software design quality assurance engineer for pre-market...improvement across the software lifecycle by implementing software industry best practices and regulatory standards ( FDA… more
- Fresenius Medical Center (Lawrence, MA)
- …Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation or ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...experience in software engineering, information technology, or software quality assurance in a regulated environment;… more
- Abbott (Alameda, CA)
- …a scientific, technical, or engineering discipline. + Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including ... written communication skills. **Preferred Qualifications** + Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools… more
- J&J Family of Companies (Santa Clara, CA)
- …Learn more at https://www.jnj.com/medtech Johnson & Johnson is recruiting for a **Senior Software Quality Engineer** , located in Santa Clara, CA. Our team ... patient outcomes and advance medical professionals' skills. The Senior Software Quality Engineer is responsible for supporting...and analytical skills + Working knowledge of IEC 62304, FDA 's General Principles of Software validation, ISO… more