Job Description

Technical Writer Role: Hybrid 2 to 3 days a week in Mesa, AZ Contract: 6 months You will be responsible for: Key Responsibilities: • Author, format, store, and update various technical documents, including Standard Operating Procedures (SOPs), Work Instructions, and Engineering Protocols (e.g., Installation Qualifications, Operational Qualifications, Performance Qualifications, and Test Method Validations). • Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components. • Manage all the existing and incoming equipment and ensure their documentation using the equipment binder. • Perform risk assessments, investigate nonconformance issues, gap analysis, and develop corrective actions. • Initiate and manage Change Requests and Change Orders to validate new and repaired equipment. • Serve as the main focal point for the component system, including data collection, data validation, meeting coordination, rollout execution, and progress updates. • Support Maintenance and Repair schedules with sufficient documentation for each piece of equipment. Your impact: About you: • Bachelor’s Degree • 3+ years’ experience in Technical Writing for Medical devices • Strong understanding of ISO 13485, ISO 14971, FDA QSR - 21 CFR Part 820 • Good understanding of regulatory compliance for medical devices • Ensure all documents conform to FDA requirements for GMP/QSR and ISO13485 • Professional experience writing technical documentation for both hardware and software in a FDA regulated environment • Ability to read and interpret engineering drawings, design and risk documents, software requirements Bill of materials, system and components specifications, assembly instructions, and test documentation • Exceptional written, organizational, inter-personal, project management, attention to detail and proofreading skills • Proven ability to work independently and in teams • Strong interpersonal, verbal communication, presentation skills and technical communication skills

Job Tags

Contract work, 2 days per week, 3 days per week,

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