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Responsible for interviewing and working with engineers, managers and other subject matter experts to develop technical product and process support documentation. This candidate should have strong communication skills which enable them to explain complex concepts in a simple manner.
Job Responsibility:
Collaborate with subject matter experts to support the creation of technical documentation and extract information to translate to documents
Analyze existing documentation to identify content gaps or inconsistencies
Effectively translates processes into easily comprehensible documentation
Orchestrates, coordinates documentation project to ensure accuracy, consistency, completeness, and delivery within the specified project deadline
Initiates and tracks document change orders
Perform other duties as assigned
Requirements:
Strong Technical Writing experience
Understanding of technical documentation (quality system procedures) in a regulated environment
Strong written and verbal communication skills
Applied Knowledge of the requirements of FDA QSR, ISO13485:2016 and ISO 14971:2012 for medical devices preferred