Auditor / Product specialist for active medical devices - Lambertville, United States - Quantum Dynamics

Quantum Dynamics
Quantum Dynamics
Verified Company
Lambertville, United States

1 week ago

Dexter Hayes

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Dexter Hayes

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Description

Job Description:

Independent planning, execution and documentation of conformity assessment procedures (audits and/or technical documentation) for manufacturers of active medical devices and their suppliers according to ISO 13485 or ISO 9001 as well as the Medical Device Directive 93/42/EEC (MDD), Regulation (EU) 2017/745 (MDR), MDSAP.

Independent planning, execution and documentation of INMETRO projects for market access in Brazil. Responsible participation in tasks/projects in the field of International Regulatory Affairs. Project handling and support of our external auditors. Independent support of our customers in Germany and abroad. Ensuring timely project completion.

Qualifications:
Successfully completed studies in the field of medical technology, electrical engineering or comparable courses.

At least four years of professional experience in the field of active medical technology, including at least two years in the design, production, testing or application of the product to be evaluated.

In-depth knowledge of electrical safety and risk management of medical devices. Independent work, accurate and precise working methods as well as empathy and sensitivity in dealing with customers. Fluent German and English skills as well as proficient use of MS Office applications. Driver's license and enjoyment of regular business trips in Germany and abroad (approx. 50%).
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