Lionbridge is seeking a motivated technical writer with an understanding of and experience with documentation standards and expectations for all activities in support of ISO 13485 Content Certification. The technical writer will be responsible for obtaining document content through research, investigation, and interviews.
Job Description:
Create, edit, and format quality manuals, training documentation, certifications, checklists, standard operating procedures, and any other supporting documentation as identified in support of product shipment readiness to facilitate ISO 13485 certification.
Specific deliverables include but are not limited to: o Create and edit quality manuals, training documentation, certifications, checklists, standard operating procedures, and any other supporting documentation as identified in support of product shipment readiness to facilitate certification. o Support all activities surrounding the creation, editing, and formatting for documentation supporting local products and process development operations. o Obtain document content through research, investigation, and interviews. o Compile and integrate graphics into documents to illustrate concepts and increase document usefulness. o Provide change management and documentation management required for documentation as determined by the project lifecycle. o Provide consulting services for content, helping to identify needs and their associated solutions. Continually offer suggestions to management to assist users with techniques of documentation and perceived documentation quality. o Obtain, synthesize, and incorporate information into schedules, timelines, and action plans to ensure document delivery meets deadlines and expecations
Required Skills:
o Advanced MS Word skills o Understanding of and experience with QMS documentation standards, records, retention, and expectations for ISO 13485 certification o Ability to adhere to established documentation conventions such as the style sheets, style guides, style conventions, etc o Ability to communicate project status to management o Attention to detail as a primary strength o Excellent written and verbal skills for effective communication o Ability to work well with remote individuals o Ability to prioritize and perform multiple tasks with minimal direction o Ability to deal with ambiguity and frequent change o Ability to understand complex technical processes, and to resolve technical ambiguity and other issues through consultation with the appropriate subject matter experts o Set up own workspace, loading/unloading software, and general problem-solving
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