This is a great opportunity to fill a 3 month gap by way of a contract role. You will be helping working with a medical device company helping to prepare technical files while working within the ISO13485 Quality Management System.
My client is a medical device manufacturer active mainly in the cosmetic field. They are expanding into international markets and is a rapidly growing business.
- Conduct design/product/process verification and validation requirements per medical device regulations 93/42/EEC, IEC 60601 and associated standards
- Preparation of technical documents such as risk analysis, FMEA, component specification, technical reports for incorporation into the technical file
- Work within ISO13485 Quality Management System
- Able to manage and maintain a Quality Management System
- Excellent knowledge of ISO13485
- Knowledge of Risk Management Device & Process lifecycle to current standards
Harris Lord is acting as a recruitment agency for this role.
Contact: Adrian Hole
Keywords: 13485, audit, manager, medical device, FDA, QMS, quality management system
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