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Medical Device Lead Auditor

Company: GMED North America.
Location: Bethesda
Posted on: November 14, 2019

Job Description:

Are you a medical device expert? Do you audit ISO 13485-based medical device systems? -If you are :a confident, reliable & certified lead auditor for medical devices, -with detailed knowledge of the audit process and international standards, as well as direct auditing experience, -GMED North America needs your knowledge, work experience, and competence to conduct:medical device audits effectively, -using quality management system standards and requirements (e.g. ISO 13485:2016, ISO 9001:2015, MDSAP),as well as European Regulations for Medical Devices CE marking (e.g. Medical Devices 93/42/EEC, Active Medical Device Implantable 90/385/EEC, In Vitro Diagnostics devices 98/79/EC).To become a Medical Device Lead Auditor with GMED North America, you -must have a bachelor degree in life sciences (such as biology, chemistry or physics, pharmacy) or an engineering degree (biomedical or bioengineering, electrical, mechanical).You shall demonstrate at least a four year professional experience in the field of healthcare products or related activities, with two out of these four years in quality management. -Your recent experience as a Medical Device Lead Auditor with another Notified Body, having acquired a good knowledge of the European Regulation related to the medical devices, is a plus for joining our team. -If you are a team player & effective communicator, with foreign language skills & International experience, able to work in a cross-cultural environment, GMED North America is your place to work at. -

Keywords: GMED North America., Alexandria , Medical Device Lead Auditor, Healthcare , Bethesda, Virginia

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