Technical Writer

Technical Writer

To provide support for the technical/validation documentation and support activities within engineering.

Responsibilities

• Perform technical writing, research, and related editing functions to prepare documents, test plans, user cases, project manuals, business proposals, reports, briefings, presentations, guidelines, and other written materials.
• To provide assistance with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively in order to meet both the TRB and CCB requirements and timelines.
• Help coordinate FMEA sessions with Engineering as needed.
• Assist with attachment and upload of deliverables associated with change control.
• Help with non-critical Validation execution under direction of Engineering.
• Assist with purchasing and spare parts ordering
• Support Engineering with planning and department development.
• Provide training on quality systems.
• Manages and monitors the change control metrics.
• Ensure accuracy and consistency of the technical/validation documentation.
• Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.
• Update procedures

Requirements

• Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
• Experience working in a regulated environment would be an advantage
• Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
• Knowledge of 21CFR 820, 21 CFR 11 and European regulations associated with the medical device industry.
• Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems.

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