- Medtronic (Boston, MA)
- …design, code implementation, unit test, and software and system verification and validation . + You will also participate in SAFe/Agile activities including but not ... and regulation - ISO 13485 and 14971, GMP guidelines, FDA regulations, Software as medical devices, and IEC 62304....The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
- Sumitomo Pharma (Boston, MA)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Teleflex (Chelmsford, MA)
- …Skills / Other Requirements** * Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements. * Computer skills, including proficiency with Microsoft Word, ... Engineering with new product development with quality planning, risk evaluation, and validation . * Perform any additional QA tasks, as assigned by QA Manager.… more