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?Job Title: Senior Technical Writer (QMS)

Job Location: ?Sunnyvale, CA

Job Type: Contract

Job Description:

• The Technical Writer ensures that the development and delivery of process documentation standard operating procedures (SOPs) are consistent and compliant with company and regulated guidelines.
• The Technical Writer writes, edits, and maintains usable, accurate, clearly presented, and consistent internal process documentation.
• The Technical Writer requires general guidance on new assignments and processes but is expected to complete day-to-day work with little instruction.
• This is a self-directed role requiring exceptional time management and communication skills.

Requirements:

• 3-5+ years of writing or editing experience in a regulated environment focusing on internal process documentation SOPs.
• Bachelor’s degree in communications, professional writing, biological/medical/engineering sciences, or equivalent.
• Strong writing and grammar skills in areas of content development and writing style.
• Analytical ability to grasp and effectively communicate complex scientific and engineering concepts
• Ability to understand and create flow charts.
• Strong organizational skills and ability to manage deliverables for multiple projects under tight deadlines, set priorities, and manage time effectively.
• Expert skill level using current versions of standard authoring tools, including Microsoft Word and Microsoft Visio.
• Working knowledge of Adobe Illustrator, Adobe Photoshop, or equivalent.
• Previous experience with medical devices or a regulated environment.
• Perform assignments with minimal instruction and supervision.

Preferred Skills:

• Understanding of Document Control processes is preferred.
• Understanding of decision tracking software such as OneNote, Excel, and Smartsheet preferred.
• Understanding of the localization process is preferred.

Essential Job Duties:

• Write, edit, and maintain internal process documentation according to company template and guidelines
• Provide ongoing writing support to cross-functional teams as they transform their processes to the new company templates and guidelines
• Develop and maintain process documentation flow charts
• Collaborate with department team members and with cross-functional team Subject Matter Experts (SMEs) to learn their internal processes to write, edit, and maintain process documentation
• Ensure compliance with Quality, Document Control, and Good Documentation Practice (GDP) guidelines
• Understand the document control steps that are required to release documentation. Upload files to the document control system.
• Resolve complex issues in creative and effective ways, using skills as an experienced technical communication professional with an understanding of industry best practices and company objectives
• Act as the lead writer on projects and mentor other writers as needed
• Keep abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Participate as required in training on regulatory issues affecting own area of work and share learned expertise with others.
• Bring regulatory compliance questions/issues to the attention of management
• Adhere to policies, procedures, style guides, and quality documents.
• Collaborate with project team members to share knowledge and best practices.