Description
A UK based Medical Device company is seeking an experienced Q/RA Consultant for a 3 month contract.The consultant will be required to split their time (5 day week) between the UK and Madrid, Spain - where the companie's manufacturing site is located.
The company, who manufactures a number of class IIb medical devices, require the candidate to be FLUENT SPANISH SPEAKING so that they are able to review the current QMS system and design documents in preparation for upcoming audits.
Experience:
- 5+ years of direct experience working with ISO 13485
- QMS Implementation
- Complaints Management CAPA
- Int/Ext Audits
- Knowledge of FDA process, submissions
- Supply Chain
- Process Driven
- Experience with sterile products and packaging would be desirable
- SPANISH SPEAKING / READING