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Keywords
Description
Qualifications:
Bachelor's degree in associated field (e.g. Technical Writing, Creative Writing, Communications, etc) or technical degree with 2+ years working experience as a technical writer or similarPrevious experience in the development and/or execution of Medical Device Quality System Regulations (i.e. FDA QSR, ISO 13485)Prior experience creating documents, procedures, and training material that support multiple elements of a medical device Quality System preferredPrior project management experience preferred
Responsibilities:
Work with SMEs and other key stakeholders to gather documentation requirements for multiple elements of a Medical Device Quality SystemCreate clear and concise Global Quality System Standards and Procedures to promote consistent, repeatable compliance based on requirements gathered from key SME stakeholdersCreate a document structure and templates that can be used as the framework for a set of global Standards and ProceduresAssist in the design, develop and deliver of training programs (e.g. e-learning, classroom) in support of the global business processes and IT solutionEnsure grammatical and spelling accuracyWork with SME team to ensure technical content is clear, concise and easy to follow