Auditor for Active Medical Devices - Togiak, AK, United States - Emerald Enterprises

Emerald Enterprises

Verified Company

Togiak, AK, United States

3 days ago

Posted by:

James Miller

beBee Recruiter

Freelance

Description

Job Description:
Since 1866, our passion has been technology and safety. Innovations have a diverse impact on our lives. 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, conduct, and document unannounced and regular audits at medical technology manufacturers
Carefully manage customer projects, particularly new clients, as the first point of contact
Independently evaluate technical documentation of medical devices
Willingness to thoroughly familiarize with ISO 13485, ISO 9001, MDR, and MDSAP standards
Support other departments in adhoc projects
Collaborate across departments on process improvement projects

Qualifications:

Successfully completed technical or scientific studies, such as medical technology, electrical engineering, or physics
Minimum of four years of professional experience in the manufacturing sector of the healthcare industry
Technical product knowledge in the field of active medical devices (e.g. imaging devices or in the cardiovascular field)
Indepth knowledge of quality management and regulatory affairs according to ISO 9001, ISO 1348
Independent