Job Description

Role: Technical Writer

Location: Irving, TX

Duration: 6 Months

Key Responsibilities:

• Create and revise technical documents: SOPs, forms, test instructions, procedures
• Translate complex technical info into user-friendly formats for engineers and technicians
• Collaborate with R&D, QA, and Process Owners for content validation
• Ensure compliance with GDP, internal quality standards, and regulatory guidelines
• Manage document version control and maintain archives
• Support training materials and participate in risk assessments/usability studies

Must-Have Experience:

• 5+ years of technical writing, preferably in medical device or healthcare
• Strong knowledge of medical terminology, FDA regulations, and GDP
• Proficiency with Document Management Systems and MS Office
• Excellent written/verbal communication skills
• Ability to handle multiple deadlines and cross-functional collaboration

Preferred:

• Background in Medical Devices, Pharma, CAPA documentation
• Experience working in FDA-regulated environments

Education:

• Bachelor’s in English, Communications, Life Sciences, Engineering, or relevant field
• Equivalent industry experience may be considered

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