|Job Ref:||204691287||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||County/State:||-||City:||Netherlands||Address:||Salary:||£90 - £100/hour travel and accommodation expenses||Post Date:||19/10/2016 02:14|
Contract: 6-12 months contract|
Pay: €90-100 per hour
Benefits: Living expenses, monthly flights home (if relocated within Europe).
Reports: Operating under the direction of the Quality and Regulatory Director
Senior Design Assurance Engineer Overview:
The Sr. Design Assurance Engineer is responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance.
The contract project will focus on reviewing the current Design History File and accordingly create a GAP analysis per file.
From here you will be establishing a corrective action plan to remediate the gaps. This corrective action plan may also include internal or external test requirements.
Senior Design Assurance Engineer- Skills and Experience:
* Circa 8 years of Medical Device Industry experience
* Bachelor's degree or higher in Engineering, Quality/Regulatory Affairs or a related discipline
* Industry knowledge of GMP, ISO 13485, FDA 21CFR820, ISO 14971 or FMEA's and other applicant standards
* Experience in production development and product introduction/ industrialisation
* Aptitude to work on highly visible projects in high-pressure situations.
For more information and to apply for this position, please send your CV with a covering note to explain why you feel you should be considered for this post.
Email: (url removed)
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