Job Description

Position: Technical Writer for Medical Devices

Location: Hybrid, 2-3 days a week in Mesa AZ

Contract: 6 Months

MUST:

• 3+ years’ experience in Technical Writing for Medical devices OR a manufacturing person who has to write SOP’s and technical documentation for manufacturing
• Experience writing standard operating procedures (SOP’s)
• Strong medical device experience
• Experience writing for manufacturing teams, experience within the manufacturing side
• Strong understanding of ISO 13485 (this is only for med devices)
• Good understanding of regulatory compliance for medical devices
• Experience ensuring all documents conform to FDA requirements for GMP/QSR and ISO13485
• Ability to read and interpret engineering drawings, design and risk documents, software requirements
• Experience taking a bill of materials (BOM’s) and making it into technical documentation

PLUS:

• Bachelor’s Degree
• Professional experience writing technical documentation for both hardware and software in a FDA regulated environment
• Utilized either Maximo or a similar tool or similar asset management tool

DAY TO DAY:

• 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.

Job Tags

Similar Jobs