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Quality Systems Administrator
1 week ago
Job Purpose
To assist with the maintenance of ISO9001:2000 throughout the Company. Ensuring all quality related documentation is current and is controlled and maintained through the electronic management system. Management of Technical Agreements to ensure they are the correct current versions and have not expired. Ensure all work is completed and is compliant in accordance with the MHRA and Home Office guidelines.
What you will deliver (responsibilities include):
- Ensure compliance with SOP's and quality related documentation,
- Ensure Technical Agreements are current and filed, monitor review dates and ensure all Technical Agreements are reviewed/approved before they expire.
- Maintenance of the Technical Agreement Log
- Ensure all quality documentation is controlled via the electronic management system,
- Filing all quality approved documentation,
- Assist with any quality related issues or requests relating to control of documents,
- Archive obsolete or superseded documents,
- Send documentation to clients as requested,
- Assist with customer/third party audits as required,
- Assist the quality team where required.
Who we are looking for:
- You must be able to work in a team and independently demonstrating a high level of performance
- You are able to work under pressure, in a busy and demanding environment, and to strict deadlines
- You will be practical with excellent organisational skills and able to prioritise
- You will have a positive attitude to seek additional tasks to develop knowledge and experience
- You will demonstrate excellent cross functional teamwork and collaboration skills
Key Knowledge, essential skills and experience needed:
Essential
- Minimum of 2 years experience of working within a quality department certified to a ISO9001 or ISO13485 standard
- Familiarisation with using an electronic document system for the control of documentation.
- Familiarisation with Quality Management Systems, ISO 900
- Experience of Microsoft packages particularly Excel, Word, PowerPoint and Outlook
Desirable
- Experience of working in fast paced office environment.
- Good working knowledge of GDP Guidelines
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