Medical Devices Technical Writer Job at Alpine Solutions Group, Mesa, AZ

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  • Alpine Solutions Group
  • Mesa, AZ

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

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

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