- Boston Scientific (Cambridge, MA)
- …- whatever your ambitions. About the role The ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects ... products portfolio. Furthermore, they will develop, establish, and maintain quality -engineering methodologies, systems, and practices which meet BSC, customer, and… more
- Katalyst HealthCares and Life Sciences (Charlton, MA)
- …preferred. CQE certification a plus. Must have knowledge of ISO 13485 and FDA /QSR Regulations. Strong computer skills with software applications for Microsoft ... Responsibilities: Responsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and… more
- Boston Medical Center (Boston, MA)
- …the information in shift change hand-off. Performs QC procedures and assesses Quality Control data according to section policy and procedures. Recognizes technical ... specific policies and procedures. Provides proper documentation of receipt, quality control performance and implementation of reagents/lots/materials. Ensures adequate… more
- Katalyst HealthCares and Life Sciences (Andover, MA)
- …Design Software Support integration activities with other teams (Firmware, Software , Systems, Mechanical, Operations & Quality ) Circuit analysis and ... Requirements: Schematic layout Circuit Design Prototype Altium 60601 PCB Med device, FDA , generating IQ/OQ Company similar to ours that realizes. Main designer for… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …principal engineers. Responsible for delivery of deliverables/solutions, meeting technical quality standards and delivery of engineering solutions that contribute to ... GAMP, and ASTM 2500 Provide support for system development, and testing both software and hardware acceptance tests (SFAT and HFAT) at vendor sites during projects,… more
- Scott & Crosby Staffing, Inc. (Boston, MA)
- …reporting to the Department of Public Health, Board of Registration in Medicine, FDA , etc., and coordinates surveys by the Department of Public Health. Assists in ... Annual reports, Semi-annual reports, Annual Disciplinary Reports, and Safety and Quality Reports (SQRs). Updates the Patient Care Assessment Committee Plan annually.… 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
- 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
- Wolters Kluwer (Waltham, MA)
- …compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities focused on 21 CFR 820, ISO ... testing activities, including verification and validation. + Lead resolution of quality issues with on-market device software ; drive investigations related… more
- Philips (Cambridge, MA)
- …regulatory and quality standards. **Your role:** + Lead clinical imaging software architecture with a balance of immediate delivery goals and future technical ... managing technical debt and prioritizing customer-centric non-functional requirements. + Ensure software compliance with medical regulatory standards like FDA ,… more
