Senior Technical Writer

Technical Writer

Hybrid 2 to 3 days a week in Mesa, AZ

Contract: 6 Months

Profile:

• 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.

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.