Technical Writer
4 weeks ago
Job Overview
As a Technical Writer, you will be responsible for producing clear, concise, and user-friendly documentation for various internal processes, including SOPs and Work Instructions. You will collaborate closely with subject matter experts, engineers, and production teams to develop comprehensive documentation that adheres to company and regulatory standards, including ISO 13485 and FDA regulations
Responsibilities
- Develop, revise, and standardize SOPs, Work Instructions, and other technical documentation.
- Collaborate with various departments to gather information and ensure the accuracy of technical documents.
- Translate complex technical concepts into easily understandable content for diverse audiences.
- Ensure all documentation complies with company policies, industry standards, and regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and GMP
- Review and edit existing documents to ensure they are current and reflect operational changes.
- Maintain a centralized repository of all technical documents and ensure easy accessibility.
- Assist in training and onboarding by providing clear and comprehensive documentation for procedures.
- Performs other related duties as assigned.
Required Qualifications
- Bachelor's degree in Technical Writing, English, Engineering, or related field.
- 2-5 years proven experience as a Technical Writer or related experience, preferably in a manufacturing, engineering or regulated environment.
- Excellent written and verbal communication skills with attention to detail.
- Strong organizational skills with the ability to manage multiple projects simultaneously.
Preferred Qualifications
- Experience in the medical device industry.
- Knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP Standards.
- Familiarity with ISO 14971 for risk management in medical device production.
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