Fresenius Medical Care
Your Profile:
- 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,
- Preferably experience in medical production quality processes for injection, extrusion, or automation (pFMEA, validation, process changes etc.),
- 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
Principal Duties & Responsibilities:
- 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 of medical machines/processes including software,
- Supporting Quality Assurance Department on the implementation of EN ISO 9001, EN ISO 13485 standards to current and new production machines/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
- Join the team for continuous improvement in quality processes.
- Collaborate in projects and teams as appropriate.
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