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Our clients, a medical devicde company based in Fareham are recruiting for a Quality Specialist to join their growing team.
The Quality Systems Specialist will ensure compliance of the Quality Management System to ISO 13485 requirements and GDP Guidelines. The QS Specialist will be focused on maintaining an effective QMS to ensure product quality and integrity through the Supply Chain.
Specific responsibilities on a daily basis:
- Manage QMS Documentation, including control of documents and records, and control of the change management process
- Implement and maintain an effective training and education programme for internal employees
- Manage Internal Audit Programme and conduct Internal Audits/Self-Inspections
- Manage and consult on Audit action plans and see actions through to closure
- Manage the CAPA process and the timeliness of CAPA closure
- Manage Supplier Approval process and records
- Manage rework process
- Manage the overall performance of the Healthcare Quality Management System on a regular basis, and see actions through to closure with other departments, customers and suppliers
- Prepare reports for Management Reviews using presentation skills and visual aids
And ad-hoc cover for additional tasks in the Quality Team, as required by Head of Quality, to meet the needs of the business
Required Skills & Experience:
- Experience in ISO 13485 Quality Assurance or GDP Quality Assurance
- Able to work in fast paced environment
- Able to work in a small business
- Attention to detail
- Critical Thinking
- Auditing would be an advantage
Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.
Gattaca Plc provides support services to Matchtech and may assist with processing your application.