Responsibilities for the Technical Writer• Co-author or contribute to the creation and revision of medical device labeling deliverables, specifically Directions for Use.
• Clearly and correctly state and summarize technical information and conclusions in instructional labeling.
• Interface cross-functionally within the product development team, and throughout the company, to acquire source material/information for instructional labeling, and to develop understanding of the products and the product development process.

Requirements for the Technical Writer

• Bachelor”s degree and 5+ years of experience working as a technical writer within the technology field, or 3+ years with an advanced degree.
• Demonstrated ability to author content using a department style guide with experience creating medical device instructions for use.
• Experience using InDesign to create medical device labeling deliverables.

Benefits

• Competitive benefits package.

Responsibilities for the Technical Writer• The quality writing tech will support quality systems and the global supply chain quality operations area.
• Work with senior QA on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges.
• Audit existing process flows within global supply chain. Create and appropriate local operating procedures for Q&C related processes and activities.
• Coordinate the effective implementation of Q&C related changes. Perform internal assessments to ensure the Quality Management System is effective, and seek continuous improvement of the system.

Requirements for the Technical Writer

• Experience in a similar role.

Benefits

• Healthcare
• 401k

• Mastery of page layout, word processing, and computer-generated illustrating using the tools In-Design, Illustrator, RoboHelp, SnagIt
• Participates on New Product Development teams for assigned products.
• Prepares the labeling plan, labeling-related standard requirements mapping and executes the plan for assigned products in the US and international markets.
• Creates, revises, reviews, and approves labeling (Help Files, User Manuals, Provider Manuals, Quick Start Guides, Product Labels, Packaging Labels.) for the US and international markets. Leads formal technical reviews for labeling.
• Supports internal and external quality audits related to labeling
• Supports CAPA’s as they apply to labeling
• Leads labeling process improvement efforts
• Partners with Translation Coordinator(s) throughout the execution of the associated labeling plans.
• Interfaces with Business Unit functions as needed to resolve labeling concerns
• Tracks the impact of pending domestic and global regulatory changes on labeling
• Conducts department training on labeling requirements
• Maintains proficiency in domestic and foreign regulations and standards, with a focus on labeling for assigned products and global impact.

• Bachelor”s degree
• Minimum of 5 years’ experience as Technical Writer

• Demonstrable excellence in command of the English Language needed.
• Organizational and project management skills needed.

• Upon offer of employment, the individual will be subject to a background check and a drug screen.

Technical Writer

Technical Writer is responsible for all aspects of written product, user and technical documentation used within the company. Technical Writer works with engineering, applications and marketing staff to update, generate, format and release new content. Technical Writer is responsible for establishing and maintaining standards, processes and quality

Role & Responsibilities

• Establish and maintain documentation work-process:

• Create process/flow for overall document development process, including request, generation, review, approval and distribution.
• Manage incoming job requests, resolve competing priorities and provide timely reports on status.
• Define and adhere to document control procedures in conformance with ISO9001 requirements.
• Provide regular status reporting on productivity, capacity and quality.

• Establish and execute documentation structure, format and deployment.

• Define document types based on content, use and audience.
• Establish standard formats for document types to insure consistency. Align formats with company standards as appropriate.
• Work with marketing to establish how documentation will be distributed to customer.
• Work with operations to insure that appropriate documentation is included with each product shipment
• Manage external translator service providers

• Generate and maintain high quality product documentation

• Edit, format and release materials provided by engineering, applications, service and other sources per process.
• Generate new source material by interviewing requestors, users and others; and by working with the software or on the product.
• Effectively manage documentation review, approval and release process
• Maintain and manage bug/feature list for continuous improvement of documentation.
• Develop and maintain effective documentation library

• Support manufacturing operations efforts by providing editing, formatting and doc-control services for work-instructions, as-needed.
• Support ISO conformance efforts

• Edit, format and release ISO documents generated by across organization
• Managing and maintaining ISO documentation using GMS system.

Qualifications & Requirements:

• Minimum 5 years of proven working experience in technical writing of software documentation
• Excellent written skills in English; strong grammar skills and attention to detail
• Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures
• Excellent organization and interpersonal skills with a strong emphasis on the ability to handle multiple tasks.
• Strong working knowledge of Microsoft Office. Experience with Adobe Framemaker preferred