Technical Writer - Manufacturing (ISO 13485)

Essential Functions

• Delivers high quality documentation and in-product text updates.
• Generates protocols, technical reports, test methods, manufacturing instructions, project planning documents, and labeling documents.
• Creates, updates, and maintains design history files, manufacturing bill of materials (BOM), routers procedures, bill of materials, travelers, and technical submission files.
• Revises instructions for use (IFUs), files, manuals, brochures, and other documentation for updated or changed product information and procedures.
• Analyzes technical documents meticulously to identify changes.u00A0
• Submits copies to management for feedback.
• Drafts and documents procedures and technical documentation from established notes, demonstrations, observations, and photographs.
• Proofreads documents to ensure clarity, proper grammar, and spelling. Conforms to departmental style guidelines and ensures documentation meets the needs of the business and the audience.
• Collaborates with internal team stakeholders to ensure alignment and execution of priorities. Participates in internal team discussions for ongoing feature work.
• Coordinates with regulatory team on technical file submissions and approval process.
• Coordinates, validates, and assists with documenting test results.
• Utilizes document control system software.
• Performs and / or supports internal and / or external audits as required.
• Performs other related duties and projects as business needs require at direction of management.

Education and Experience :

Pay Range : $28.50-$36.00 / hru00A0

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