- Philips (Cambridge, MA)
- …(PMS) plans are made and include all stages of the product life cycle + Supports Quality Plan design for hardware and Software design and ensure they meet ... + You have a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design… more
- Medtronic (Boston, MA)
- …world. **A Day in the Life** A Day in the Life of a Principal Quality Engineer, Post-Market Risk Responsibilities may include the following and other duties may be ... tools and techniques * Significant breadth and depth in quality decision making, risk management, quality engineering,...and writing for compliance. * Knowledge and expertise in FDA 21 CFR 820 & 806, EU MDR (Regulation… more
- Philips (Cambridge, MA)
- … FDA regulated Medical Device/HealthTech product environments. Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired. ... product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance standards/requirements.… more
- Sanofi Group (Cambridge, MA)
- …and mitigation strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between various systems ... processes, and meet the business needs with the agreed quality of service. + Responsible throughout the entire project...while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work closely with QA and… more
- Sumitomo Pharma (Boston, MA)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... including computer word processing, electronic document management systems, and regulatory publishing software . + Robust understanding of FDA and other health… more
- Cytel (Cambridge, MA)
- …programmers to ensure that data summaries are delivered in a consistent, high- quality manner. This individual will be responsible for implementing all reporting and ... collaboration with a Statistician), and complex graphs + Deliver high- quality statistical programming results including developing, validating, and maintaining SAS… more
- J&J Family of Companies (Danvers, MA)
- …medical devices. This senior-level role is critical to ensuring product quality and regulatory compliance through robust validation strategies across both manual ... validation strategies in a fast-paced environment, working cross-functionally with Manufacturing, Quality , R&D, and Regulatory teams. Your deep expertise will help… more
- Merck (Boston, MA)
- …& Development) by: + Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel ... regulatory obligations, compliance requirements and company strategy. + Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Hologic (Marlborough, MA)
- …this role, you will leverage your expertise in design control, risk management, software development, and quality systems to ensure our medical devices, ... test cases and inspection procedures. + Understanding of Software Development Life Cycle (SDLC) + ** Quality ...knowledge of **SaMD** , including regulatory requirements such as FDA 21 CFR Part 820 (Design Control), ISO 13485,… more
- Medtronic (Boston, MA)
- …highly regulated environment with a cross functional group of highly talented software developers, test engineers and quality engineers, collaborating with ... HW and systems partners, including integration team, testing team, Quality , System V&V etc. Must Have: Minimum Requirements Requires...and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and… more
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