- Philips (Cambridge, MA)
- …+ **Compiles** and **analyzes** clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. ... evidence generation, and surveillance/safety). **Your role:** + **Leads** the medical writing team in planning and delivering high- quality...4, EU Medical Device Regulation). + **Author** and **maintain** clinical documentation, including… more
- Philips (Cambridge, MA)
- …and execution to drive continuous quality improvements in the design of Medical Device products and systems to world-class levels, in close, cross-functional ... -in-design tools, technologies, processes and techniques, with a specific focus on medical device -product/systems design to arrive at first time right, safe,… more
- Teleflex (Chelmsford, MA)
- …such as metric reporting, document control, and audit participation. A strong background in quality assurance within the medical device industry, along with ... document retention policies, Good Documentation Practices and archiving / scanning Device History Records *Analyze and review quality system documents… more
- Abbott (Burlington, MA)
- …various types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global ... providing information on product complaints to various teams (eg Regulatory , Quality Engineering). The other role of...work experience **Preferred Qualifications** + 3+ years in MDR ( Medical Device Reporting) + Knowledge of the… more
- Sanofi Group (Framingham, MA)
- …science, or equivalent with at least 10 years relevant experience in the pharmaceutical, biotech, medical device or a related industry or at a Regulatory ... **Job Title:** Global Quality Lead, GMP, GDP Audit and Inspection -...secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity,… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …and Word. + Knowledge of FDA QSR required + Knowledge of USA and international regulatory Medical Device Reporting preferred. + Must be able to communicate ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Teleflex (Chelmsford, MA)
- …of quality engineering or design assurance experience (preferably in the medical device industry). **Specialized Skills / Other Requirements** * ASQ ... Quality Engineer 2, Design Assurance PMS **Date:** Aug...:12410 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... and get on with their lives. We are seeking an experienced **_Staff Software Quality Engineer_** to ensure our medical devices are developed in accordance with… more
- Integra LifeSciences (Braintree, MA)
- … mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring ... (Biomedical or Mechanical) or related discipline, with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing,… more
- Sanofi Group (Cambridge, MA)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... market auto-injectors, pens, safety syringes, as well as connected medical device technologies, and we are gearing...equipment, printing, and vision control systems. + Knowledge of device and packaging regulations, quality systems, design… more