East Riding of Yorkshire, England
£150 - £200 per day
2 months ago
1st Executive are recruiting a Quality Management Systems Specialist on behalf of a fantastic British manufacturing organisation known all over the world. They are seeking a switched on, Quality Management Systems Specialist with preferable experience in Medical Device / Pharmaceuticals.
This is a fantastic opportunity to extend your knowledge working in a regulated environment and add a great name to your CV. Long contract of 6 months paying a very competitive rate.
To assist in the development, maintenance and co-ordination of the Quality Management Systems (QMS), supporting the Implementation of changes to Company Global Policies, Regulations and International Standards into the Hull Quality Management Systems whilst complying with company Quality Systems and applicable Regulations & Standards, Health & Safety Requirements and Site Safety Policy.
- To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures
- To perform all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices
- To ensure that all Quality Systems external communications including customer postal audit responses are of an acceptable standard to meet customer needs and facilitate improvement where necessary
- To assist and support the internal audit schedule in accordance with the procedure, to ensure compliance and timely close out of improvement actions
- To support the integration of Global Policies and updated Regulatory & International standards requirements into the Hull Quality Systems.
- To support the Correction & Removal Evaluation process, tracking progress of any resulting Field Safety Corrective Actions
- To input and manage date within existing Quality System databases
Essential required experience:
- At least 3 years' experience working within Quality Assurance, preferably with Medical Devices / Pharmaceutical Industry
- Awareness / understanding of the Medical Device Directive, GMP, GDP, ISO 9001, ISO 13485, 21 CFR Part 820
- Trained auditor desirable
- IT skills and spreadsheet knowledge
If this position is of interest, please apply now and if you have any questions please call Elliot Fisher on 01483 212186.