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R & D DOCUMENTATION TECHNICAL WRITER
Company:RFT GROUP |
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Job Reference Number |
13538122 |
Client ID: |
RI/RFT 90882/28 |
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Posted On: |
Jul 8 2009 |
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Location: |
GALWAY |
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Job Type: |
Contract |
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Salary: |
NOT DISCLOSED |
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We have an opportunity for a Technician writer to join the Research and Development Department on a 12 month contract
This Technical Writer will work as a team member on a Recertification Project primarily supporting the following deliverables / tasks:
§ Creation of Use Flowcharts
§ Facilitate and contribute to the creation of the Use FMEA and drive to completion
§ Facilitate and contribute to the creation of revised Risk Management Deliverables (Risk Management Plan / Report and Hazard Analysis) and drive to completion
§ Design History File Owner, ensure DHF is accurate and all required project deliverables appropriately filed. Responsible for DHF audits and communication of findings to the project team
§ Ensure that the Recertification Quality Plans are updated as required to reflect progress.
§ Provide CAPA support as required.
§ Own / contribute to other project deliverables as required.
Key Responsibilities
§ Co-author or contribute to the creation and revision of engineering deliverables, driving documents from draft to completion.
§ Clearly and correctly state and summarize technical information and conclusions in documents.
§ Manage, organize, and communicate project information and project activities. As needed, develop tracking tools for team use and communicate status for activities critical to project timeline.
§ Apply corporate and regulatory documentation requirements.
§ Organize and place raw data into usable tables.
§ Plan documents and create the draft or framework of a document for the engineer or team.
§ Participate in or lead department projects.
Interface cross-functionally within the product development team to acquire source material for documents and to develop understanding of the products and processes.
§ Critically review document content to ensure accuracy with SOP requirements and ask challenging questions to refine the clarity of document content.
§ Make suggestions or corrections in order to make a document more clear and concise.
§ Assist in the development and maintenance of technical writing processes and practices
§ Provide support to organization for locating documents, records, or other information
§ Initiate document Change Request approvals.
§ Manage the project records during development.
§ Build Quality into all aspects of work by maintaining compliance to all quality requirements
Qualifications
§ Certificate/Diploma in a related technical field
§ Must have a minimum of (2-5 years typical) of professional technical writing experience, medical device or other regulated industry preferred.
§ Must have strong writing, editing, communication, and negotiation skills.
§ Must have expert knowledge of Microsoft Word and a working knowledge of Microsoft Excel and PowerPoint. Knowledge of Microsoft Visio desired.
§ Must demonstrate attention to detail.
§ Must have the ability to work both in collaboration with others on a project team and independently on tasks.
§ Must have the ability and desire to keep track of document and project details.
§ Must be able to work quickly and efficiently on documents and tasks while still maintaining high quality in work.
§ Must demonstrate initiative for creating, reviewing, and initiating approval for documents and commitment to overall project deadlines.
§ Must demonstrate proactive work habits and assertiveness in creating and owning documents.
§ Must have an aptitude to understand engineering and other technical information.
§ Must have project management and time management skills.
Must have problem solving skills and an ability to respond and adapt to change
Call Eimear Moroney, on 01 2302400, 085 7874500, Eimear@rftgroup.ie
for further information or email your CV through the relevant link. No CV or details will be submitted to any potential client without prior knowledge, discussion and consent from "every" candidate.
The RFT Group: BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website: www.rftgroup.ie www.meddevicejobs.ie
