- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, USA) ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product-Regulatory-Manager\_R2060938/apply) Return to Job Finder At Dow, we believe… more
- Abbott (Westfield, IN)
- …and work experience **Experience/Background** + Minimum 2 years of Software Quality Engineering experience + Detailed knowledge of FDA , GMP, IEEE 1012 ... Our 114,000 colleagues serve people in more than 160 countries. **Engineer II Software Quality ** **About Abbott** Abbott is a global healthcare leader, creating… more
- Abbott (Sylmar, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. **Job Title** ** Software Quality Engineer II** **Working at Abbott** At Abbott, you can ... **The Opportunity** Our location in **Sylmar, CA** currently has an opportunity for an ** Software Quality Engineer** . **This is a fully onsite role** . This… 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
- 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
- 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
- Stryker (Weston, FL)
- **Senior Staff, Software Quality Assurance Engineer** Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital ... with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including 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
- Insight Global (Bedford, MA)
- … software compliance, including cybersecurity and privacy. Ensure product quality and documentation meet standards before approval. Support product development ... This role ensures that design control and risk management activities for software and digital medical products (SaMD, SiMD) meet all required procedures, standards,… more