Expert in Orthopedic Medical Devices - Kramer, ND, United States - NovaWorks

NovaWorks
NovaWorks
Verified Company
Kramer, ND, United States

2 weeks ago

James Miller

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James Miller

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Freelance
Description

Job Description
Since 1866, our passion has been technology and safety.

Innovations have a diverse impact on our lives, and every day we strive to ensure the safety of people and society, building trust in new technologies.

We are part of progress. We advise, test, and certify. We act with conviction, shaping the world of tomorrow today - making a difference. We take the future into our own hands. We are TÜV SÜD - 25,000 employees at 1,000 locations worldwide.


Responsibilities

  • Independently plan, monitor, and manage customer orders in a complex regulatory environment as a Project Handler
  • Expert career path for orthopedic and dental medical devices as an Assessor (auditing and technical documentation) in direct contact with customers
  • Willingness to authorize and intensively familiarize with requirements from ISO 13485, ISO 9001, MDR, and MDSAP, including relevant standards
  • Crossdepartmental support for ad hoc inquiries and collaboration in process improvement projects
  • Main point of contact for assigned new customers and support projects

Qualifications

  • Successfully completed technical or scientific studies, e.g. in Medical Technology, Electrical Engineering, Biology, or a related field
  • Professional experience in a manufacturing environment in the field of bone cements and/or orthopedic implants and/or dental implants
  • Knowledge in Quality Management / Regulatory Affairs (e.g. ISO 9001

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