ALNYLAM US INC – $127,566.00/Year

Applicants must have demonstrated experience withbr br Device or combination product cGMP;br Quality EngineeringAssurance role;br Global Device and Combination Product regulations, standards, and guidelines 21 CFR Part 4, Part 803, Part 820, ISO 13485, ISO 14971, or ISO 62366;br Providing Quality Assurance support for an inclinic or onmarket product designrelated continuous improvement efforts, devicerelated exceptions, supporting complaint investigations, CAPAs, or change controls;br Maintaining design history, human factors, and risk management files throughout the product lifecycle for onmarket products;br Providing quality oversight of external partners suppliers, CMOs, or CTOs, including conducting external audits and authoring quality agreements;br Translating and implementing evolving regulatory requirements into a corporate QMS including experience leading the creation and revision of SOPs in an electronic document control system.