Lead Analyst

4 weeks ago

Fremont, United States GForce Life Sciences Full time

Responsibilities:

  • Conducts thorough reviews and audits of technical publications to ensure quality documentation delivery, leading problem-solving initiatives to resolve complex technical issues.
  • Develops training and communication materials for conveying new or updated processes, including SOPs, Work Instructions, and forms, ensuring clarity and comprehension.
  • Researches and documents product, service, and technology knowledge in a clear and logical manner for reader comprehension.
  • Supports quality policy adherence by integrating quality into all aspects and contributing to continuous improvement initiatives.
  • Prepares for and leads internal and external audits, manages recertification projects, and drives compliance efforts in collaboration with stakeholders.
  • Contributes to process improvements and strategic programs aimed at reducing error rates and improving efficiency.


Requirements:

  • 4-6 years of experience in developing technical publications within a regulated industry, preferably medical devices.
  • Bachelor’s Degree in Graphics, Language, or equivalent field; advanced degree considered towards experience.
  • Proficiency in Microsoft Applications (Word, Excel, PowerPoint, Visio) and Adobe Suite (InDesign, FrameMaker, Photoshop, Illustrator).
  • Experience with Instructions for Use, Training Guides, Electronic IFU (eIFU), translation management, and website support.
  • Strong organizational skills, ability to manage varied workloads, and deliverables within tight timelines.
  • Commitment to Good Document Practices (GDP) and continuous learning to stay current in the field.
  • Familiarity with database-driven labeling systems (e.g., Prisym ID, Loftware) and Computer-Aided Drafting (CAD) software (Solidworks, AutoCAD) is advantageous.

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