Technical Writer

Document Control | Santa Ana, CA

Job Function:

We are hiring a Technical Writer for our Document Control and Operational Excellence group. The Technical Writer will be responsible for the preparation and review of protocols, reports, procedures, training materials and other documents for multiple departments at FUJIFILM Irvine Scientific. The person in this role will create, develop, plan, write and edit operational, instructional, maintenance and test procedures.

Job Duties:

  • Conduct interviews with various users and technical staff to gather data for documentation
  • Research and translate technical information into documents for nontechnical and technical users
  • Recommend formats responsive to technical and customer requirements
  • Perform quality control (QC) checks of draft documents to ensure the accuracy of the data and resulting subsequent conclusions
  • Review documents for style, clarity, grammar, and punctuation
  • Produce products that conform to the company documentation and quality assurance standards

Experience/Education:

  • Bachelor’s degree required
  • At least 4 years of relevant experience in a Medical Device or Pharmaceutical organization
  • Knowledge of current industry regulations, e.g. cGMP, ISO 13485, 21 CFR Part 820, TGA and Canadian Medical Device Regulations strongly preferred
  • Experience writing software instructions or validation documents a plus
  • Computer skills, specifically MS Word, Excel, Gmail
  • Exceptional written and verbal communication skills required

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Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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