Quality Assurance Specialist
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.
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.