- Medtronic (Boston, MA)
- …connected, compassionate world. A Day in the Life of a Post-Market Risk, Quality Engineering Manager - reporting to Director of Post-Market Risk, Surgical Operating ... Operating Unit's (SOU) Post-Market Risk Management of medical device products or software systems. * May develop, evaluate, implement and maintain technical … more
- Hologic (Marlborough, MA)
- …gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a ... representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a… more
- Bristol Myers Squibb (Devens, MA)
- …here at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A2 Shift (6pm to 6am), you will lead a ... team of 4-8 Specialists. The Shop Floor Quality Assurance team is responsible for 24x7 ...etc., and ability to learn and work with new software applications. + Advanced ability to interpret data &… more
- 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