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Quality assurance specialist

Enfield
Fresenius Medical Care North America
Quality assurance specialist
Posted: 27 October
Offer description

QUALIFICATIONS

* Graduated from universities' Science or Engineering (biology, chemistry, etc.) Departments
* Quality management system standard experience (EN ISO9001, EN ISO13485)
* Preferably, experience in the field of medical device quality management system and medical device regulation
* Preferably having knowledge and experience in statistics and reporting
* Medical sector experience is an asset
* Full Professional Proficiency in English
* Good at Office Applications & Computer
* Strong communication and negotiation skills
* Dynamic, disciplined and focused to responsibilities
* Preferably not exceeding 40
* Will be able to reside in Antalya
* For male candidates, there is no military obstacle


JOB DESCRIPTON

* Supporting Quality Assurance Department on the evaluation of the effectiveness and efficiency of the quality management system, mainly with focus on the change management, pFMEA and validation activities including software
* Supporting Quality Assurance Department on the implementation of EN ISO 9001, EN ISO 13485 standards to current production process and practices as required, helping training organizations
* Presents or arranges for the presentation of training on quality system topics.
* Contribution to the definition and implementation of QS relevant projects
* Contribution to the implementation of QS relevant software support
* Collaborate in projects and teams as appropriate
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