- Dana-Farber Cancer Institute (Methuen, MA)
- …compliance with all regulatory agency (eg Joint Commission (formerly JCAHO),CAP, FDA , AABB) requirements. + Manual/visual dexterity necessary to prepare specimens, ... prepare solutions, screen specimens and operate a computer software system. + Ability to perform venipuncture techniques. At Dana-Farber Cancer Institute, we work… more
- ZOLL Medical Corporation (Boston, MA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Medtronic (Billerica, MA)
- …or equivalent systems. + **Programming:** Set up, configure, and validate firmware/ software builds on capital equipment using proprietary test environments and ... electrical test equipment and basic troubleshooting + Experience in a regulated environment ( FDA , ISO 13485) + Ability to read and interpret schematics, BOMs, wiring… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Supply Chain Management to ensure surgical implants are Federal Drug Administration ( FDA ) approved. Completes a variety of non-supervisory ad hoc projects and ... basic knowledge of inventory management procedures; ability to use computer software packages for word processing, spreadsheet development, and database management;… more
- Fujifilm (Boston, MA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Aseptic Areas. + Experience in Blue Mountain (RAM), Calman, or Procal Software is highly preferred. Must possess experience in: + Temperature + Technologies… more
- Chewy (Boston, MA)
- …cost efficiency. + Collaborate with procurement, transportation, operations, merchandising, software engineering, suppliers, and the Chewy packaging lab to ... Preventive Controls Qualified Individual (PCQI) training. + Working knowledge of FDA regulations, including 21 CFR Part 507.27 (Current Good Manufacturing Practice… more
- Sumitomo Pharma (Cambridge, MA)
- …Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency ... in BASE SAS and R, or other statistical software is advantageous + Effective verbal and writing skills **Education and Experience** + PhD or MS in statistics or… more
- Philips (Cambridge, MA)
- …right fit if:** + You have a minimum of 5+ years' experience within FDA regulated medical device Quality environments, with a focus on CAPA reviews, investigations, ... workflow. + You're able to understand/analyze complex problems, including software /hardware design issues and have demonstrated knowledge of the tools/techniques… more
- Sumitomo Pharma (Boston, MA)
- …risk assessment, and safety data analysis + Proficiency with safety databases and software + Ability to evaluate and write case reports and prepare regulatory ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more