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Quality Assurance Engineer

GETINGE

Antalya(Konyaaltı)

İş Yerinde

İş Yerinde

Job Type

Full-Time

Position Level

Specialist

Department

Quality

Quality

Application Count

171 application

Job Type

Full-Time

Position Level

Specialist

Application Count

171 application

Department

Quality

QUALIFICATIONS AND JOB DESCRIPTION

Ever since Maquet's founding in Germany in 1838, it has helped hospitals with innovative products such as the first motorized operating table. A Maquet table was used for the first heart transplant surgery in 1967, in South Africa. Firsthand understanding of clinical challenges and continuous optimization of its products established Maquet as a leading provider of medical systems.  

Today Maquet is a product brand within Getinge. The Maquet brand provides a broad range of products and innovative treatment solutions and infrastructure functions for extremely demanding hospital departments, including operating rooms, hybrid operating rooms, catheter laboratories and intensive care units as well as intra- and inter-hospital patient transportation. 

The production is conducted at facilities in Brazil, Dominican Republic, France, Canada, China, Germany, Poland, Sweden, Turkey, the UK and the US. In total, Getinge has over 12.000 employees in more than 41 countries. Getinge's head office is located in Gothenburg, Sweden.

 

Job Description :

‘’Two employees will be hired for this position and some of below processes will be distrubuted among these employees’’

  •  CAPA management, effective use of OneTrack/Trackwise system, review of investigation results, planned corrective and preventive actions and effectiveness check results, make key decisions on the failures, making sure that closed CAPAs are totally handled in accordance with applicable regulations like ISO 13485 & 21CFR 820.
  •  Lead and assist in compliance mitigation and continuous improvement projects and closing gaps, contribute  in standard review meetings
  • Responsible for Nonconforming product management, effective use of QDMS system, improvement of nonconforming product management system, review of nonconformity investigations, make key decisions on the failures, making sure that closed nonconformities are totally handled in accordance with applicable regulations like ISO 13485 & 21CFR 820.
  •  Responsible for product release activities (final release documentation-COC, Sterilization DHRs release,  Production DHR files release, environmental monitoring records)
  • Responsible for  MAQUET’s internal audit program. Perform internal quality system audits to evaluate the quality system for compliance with applicable regulations and standards in support of continuous quality system improvement. The candidate will lead the post-audit process to ensure corrective action activities are supported by the action owners through to effective implementation.
  •  Contribute to the management of the document control system; ensure creation, changes, distribution and retention of records compliant to QMS requirements
  • Responsible for training of employees on quality related aspects
  • Responsible to follow up the Quality Plans and ensure timely and compliant implementation
  •  Contribute to change management process, implementation and review or approval changes
  • Contribute to review and approve product technical documentation acc. to applicable regulations or QMS procedures
  • Responsible for providing engineering support and ensuring quality compliance in accordance with documented procedures for all aspects of functional responsibility.

Qualifications:

  • Bachelor degree in Engineering and technical or Health/Life Sciences departments of universities.
  • Min 2 years of experience in Quality Management Systems preferably in Medical Devices Industry
  • Knowledge of tools/ methodologies such as design control, risk management, root cause investigation methods, process validation, statistical process control (SPC), protocol/ report preparation.
  • Knowledge of ISO 13485, European Medical Device Regulation and FDA 21 CFR820  requirements, understanding the medical device regulatory environment and requirements
  • Familiar with QMS processes like Technical File preparation, CAPA, Complaint management, document control, internal audit etc.
  • Good knowledge of MS Office applications is required and SAP is an asset
  •  Advanced statistical data analysis, documentation and report writing skills
  • Good command of English is compulsory, German knowledge would be an asset
  • Exceptional analytical, problem solving & root-cause analysis skills
  • Internal auditor certification preferred
  •  High level of attention to details and accuracy
  • Excellent communication skills, ability to work in a team environment and lead a project team
  • Ability to lead or work with multi- departmental project teams and resolve quality related issues in a timely and effective manner
  •  6 Sigma certification preferred
  • Be self-motivated, self-starter, be able to meet deadlines, be a good team player, be able to assist and support others
  •  Details oriented 
  •  Result oriented
  • Be open-minded and willing to learn
  • Ability to travel as required

Preferred Candidate

2 - 99 years of experience
Bachelor’s(Graduate)
Completed, Exempt

Kalite Güvence Mühendisi pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Kalite Güvence Mühendisi Kalite Güvence Mühendisi Maaşları Kalite Güvence Mühendisi Nasıl Olunur? Kalite Güvence Mühendisi Nedir? Kalite Güvence Mühendisi İş İlanları

Medical products

Hakkımızda

Hayata Duyduğu Tutkuyla... Her bireyin ve topluluğun mümkün olan en iyi bakıma erişmesi gerektiğine olan kesin inancıyla Getinge, hastanelere ve yaşa

Şirket Sayfasına Git
Şirketin Aydınlatma Metni

GETİNGE GROUPMaquet Cardiopulmonary Medikal Teknik San.Tic.Ltd.Şti.KİŞİSEL VERİLERİN İŞLENMESİ ÇALIŞ

Detaylı Bilgi
Yan Haklar

Özel Sağlık Sigortası, Servis, Kreş, Yemekhane, Bayram Yardımı, Bireysel Emeklilik.

Kalite Güvence Mühendisi pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.

Kalite Güvence Mühendisi Kalite Güvence Mühendisi Maaşları Kalite Güvence Mühendisi Nasıl Olunur? Kalite Güvence Mühendisi Nedir? Kalite Güvence Mühendisi İş İlanları