Quality

An exciting new opportunity has become available for a Quality Engineer in a market leading medical device firm based in theUK. Candidate must be a proven individual with working experience in supporting Quality and Product Development teams and have an accredited ISO 13485.

Candidate's responsibilities will be, supporting the Quality Assurance, Product Development, R&D and Manufacturing departments and the position involves the following competencies;

* ISO 13485- Quality Engineering- FMEAS, Design Approval, Verification and Reviews, QA Review, Process
* Risk Management
* USFDA, BSEN.
* Provide support to production and R&D ensuring new and existing products and equipment meet the companies' current validation requirements.
* Liaise with other departments to ensure the processes and procedures needed to maintain validated systems are established, understood and implemented.
* Write and execute validation documents

The candidate must have 2 years Quality Engineering experience gained specifically in a Medical Device business and will have experience in supporting Quality and Product Development teams with an accredited ISO 13485 QMS

Quality Engineer Requirements;

* Quality Engineering- Risk Management, FMEAS D&P, Design
* Quality Review and QA Processes
* Risk Management
* USFDA , BSEN Standards
* Audit consultant experience in ISO13485, MDD93/42/EEC & ISO9001
* Expertise in the validation of solids processing with an appreciation of the principles of DoE and Quality by Design
* Expertise in the validation of modern analytical techniques
* Experience in the validation of manufacturing processes and the associated scale up activities

If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to contact me on 0207 758 7322To find out more about Real please visit www.realstaffing.com