Technical Writer Job at Integrated Resources, Inc ( IRI ), Middletown, Frederick County, VA

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  • Integrated Resources, Inc ( IRI )
  • Middletown, Frederick County, VA

Job Description

Job Title: Technical Writer II

Location: Middletown, VA

Duration: 9 Months

We’re Hiring! 🚀

Join our dynamic team in making a difference in the lives of patients by supporting software product development in a fast-paced and innovative environment. We are seeking a Technical Writer II to contribute to the development of software diagnostics products that have a real impact on patient care.

As a key contributor to our R&D team, you will be responsible for managing the documentation lifecycle for software products, including design control deliverables, verification and validation protocols, and more. You’ll collaborate with cross-functional teams to create high-quality, well-organized documentation in compliance with industry standards and regulatory guidelines.

Key Responsibilities:

  • Develop documentation for new software products in accordance with FDA and international guidelines (IEC 62304, 21 CFR Part 11).
  • Support the creation of Design History Files for new product development.
  • Write, edit, and finalize documentation, including Design and Development Plans, Test Methods, Validation Protocols, FMEAs, and SOPs.
  • Manage document change control and ensure compliance with quality procedures.
  • Create customer-facing documentation such as user guides and training manuals.
  • Collaborate with cross-functional teams to gather and incorporate feedback.
  • Maintain integrity of documents to comply with good documentation practices (GDP).

Qualifications:

  • Bachelor's degree in a related field + 5 years of experience in technical writing.
  • Excellent written and verbal communication skills.
  • Proficient in Microsoft Office and other documentation tools.
  • Knowledge of FDA regulations for software product development.
  • Ability to thrive in a fast-paced environment and drive project progress.
  • Highly collaborative, with a positive, team-oriented mindset.

Job Tags

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