- 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).
- 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.
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Technical Writer - Middletown - Integrated Resources, Inc ( IRI )
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:
Qualifications:
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Technical Writer
Only for registered members Middletown
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Technical Writer
Only for registered members Middletown
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Technical Writer
Only for registered members Middletown
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Technical Writer
Only for registered members Springfield, VA
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Senior Technical Writer Editor
Only for registered members Washington, VA
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Service Writer
Only for registered members Woodstock, VA
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Senior Writer Project Manager
Only for registered members Washington, VA
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Speech Writer
Only for registered members Washington, VA
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Digital and Content Writer
Only for registered members Washington, VA
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Content Operations Specialist
Only for registered members Luray
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Senior Airborne Electronic Attack Subject Matter Expert
Only for registered members Springfield, VA
-
Metrics Analyst
Only for registered members Washington, VA
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Support Lead II
Only for registered members Winchester, VA